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PEN NEEDLE 31GX5MM 7 PACK Adverse Event — Injury (MDR 3006948883-2020-00154)

PEN NEEDLE 31GX5MM 7 PACK Adverse Event — Injury (MDR 3006948883-2020-00154) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PEN NEEDLE 31GX5MM 7 PACK; Generic name: PEN NEEDLE; Manufacturer: BD (SUZHOU).

DevicePEN NEEDLE 31GX5MM 7 PACK
Generic namePEN NEEDLE
ManufacturerBD (SUZHOU)
Report number3006948883-2020-00154
Event typeInjury
Product problemY
Date received2020-04-28
Report sourceFOREIGN, OTHER, USER FACILITY
NarrativeINVESTIGATION SUMMARY: DHR WAS REVIEWED AND NO QN FOUND. MANUFACTURE RECORDS WERE REVIEWED, NO ABNORMAL WAS FOUND. INCOMING INSPECTION REPORT OF THE CANNULA WHICH USED FOR THIS LOT, AND ALL TEST RESULTS MEET THE SPECIFICATION. INSPECTED 7PCS RETENTION PARTS CANNULA ANGLE, CANNULA APPEARANCE AND CANNULA PULL FORCE. ALL RESULTS PASSED. PEN NEEDLE PRODUCT HAS 100% IV HEIGHT,ANGLE,POINT INSPECTION BY
SourceopenFDA MAUDE (device adverse events)

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