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).
| Device | PEN NEEDLE 31GX5MM 7 PACK |
|---|---|
| Generic name | PEN NEEDLE |
| Manufacturer | BD (SUZHOU) |
| Report number | 3006948883-2020-00154 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN, OTHER, USER FACILITY |
| Narrative | INVESTIGATION 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 |
| Source | openFDA MAUDE (device adverse events) |
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