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BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET Adverse Event — Malfunction (MDR 1024879-2020-00293)

BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET Adverse Event — Malfunction (MDR 1024879-2020-00293) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET; Generic name: BLOOD SPECIMEN COLLECTION DEVICE; Manufactu

DeviceBD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
Generic nameBLOOD SPECIMEN COLLECTION DEVICE
ManufacturerBECTON, DICKINSON & CO., (BD)
Report number1024879-2020-00293
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceFOREIGN, OTHER, USER FACILITY
NarrativeH.6. INVESTIGATION SUMMARY : BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE H.10.
SourceopenFDA MAUDE (device adverse events)

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