BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G
Report
- Report Number
- 9616656-2022-00200
- Event Type
- Malfunction
- Date Received
- February 17, 2022
- Date of Event
- February 7, 2022
- Report Date
- March 17, 2022
- Manufacturer
- BECTON DICKINSON AND CO.
- Product Code
- FMI
- UDI-DI
- 10885403811012
- PMA / PMN Number
- K162516
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.
DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES D.9. RETURNED TO MANUFACTURER ON: (B)(6) 2022. H.6. INVESTIGATION: CUSTOMER RETURNED A TOTAL OF 48 USED 5MM, 31 GAUGE PEN NEEDLES. NO TEAR DROP LABELS WERE RETURNED FOR LOT IDENTIFICATION. OF THE 48 SAMPLES RETURNED, 36 WERE FOUND TO HAVE SOME MEASURE OF DAMAGE TO THE NON-PATIENT END. 35 CANNULAS WERE BENT AND 1 WAS BROKEN ON THIS SIDE. THIS DAMAGE WOULD PREVENT TESTING FOR CLOGS SINCE THE NEEDLE CANNOT PROPERLY ATTACH TO THE PEN. AS A RESULT, THE PEN NEEDLES APPEAR TO BE CLOGGED DURING USE. BASED ON THE DAMAGE PRESENT, THE NEEDLES BENDING OR BREAKING MAY HAVE OCCURRED ACCIDENTALLY WHILE THE USER WAS PREPARING THE PEN NEEDLE FOR USE, POTENTIALLY IF THE PEN WAS NOT PROPERLY ALIGNED WITH THE CANNULA. THE REMAINING 12 SAMPLES WERE ATTACHED TO A TEST PEN FILLED WITH SALINE. SALINE WAS PUSHED THROUGH THE SYSTEM AND OUT THE DISTAL TIP OF THE REMAINING PEN NEEDLES. NO ISSUES WERE FOUND WITH THE REMAINING PEN NEEDLES. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.
IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G A NEEDLE WAS UNABLE TO DELIVER ITS MEDICATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320119 BATCH NO: 1202183 & UNKNOWN. IT WAS REPORTED BY THE CONSUMER THE NEEDLE CLOGGED DURING THE INJECTION.
IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G A NEEDLE WAS UNABLE TO DELIVER ITS MEDICATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320119 BATCH NO: 1202183 & UNKNOWN. IT WAS REPORTED BY THE CONSUMER THE NEEDLE CLOGGED DURING THE INJECTION.
IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G A NEEDLE WAS UNABLE TO DELIVER ITS MEDICATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320119 BATCH NO: 1202183 & UNKNOWN. IT WAS REPORTED BY THE CONSUMER THE NEEDLE CLOGGED DURING THE INJECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1937386 | BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON AND CO. | 8110 | 1202183 | 10885403811012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |