BD NANO¿ 2ND GEN PEN NEEDLE
Report
- Report Number
- 9616656-2022-01018
- Event Type
- Malfunction
- Date Received
- September 21, 2022
- Date of Event
- August 26, 2022
- Report Date
- November 2, 2022
- Manufacturer
- BECTON DICKINSON AND CO.
- Product Code
- FMI
- UDI-DI
- 00382903205509
- PMA / PMN Number
- K212015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- 003
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 0274099. D4: MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2025. H4: DEVICE MANUFACTURE DATE: 30-SEP-20. D4: MEDICAL DEVICE LOT #: 9338807. D4: MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2024. H4: DEVICE MANUFACTURE DATE: 04-DEC-2019.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 30-SEP-2022. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (51) TOTAL 32GX4MM BD PEN NEEDLES (40 FROM LOT# 0274099, 5 FROM LOT# 9338807, AND 6 FROM LOT# 1223681). THE CUSTOMER REPORTED THAT THE HUB IS FALLING APART/BROKEN/NOT GLUED TOGETHER PROPERLY. THE SAMPLES WERE EXAMINED, AND IT WAS OBSERVED THAT NONE OF THE SAMPLES EXHIBITED A BROKEN HUB, AND NO DAMAGE TO THE HUBS WAS OBSERVED. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. THE ALLEGED ISSUES COULD NOT BE CONFIRMED BASED ON THE SAMPLES RETURNED FOR INVESTIGATION. 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. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER E-MAIL: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) THE GLUE ON THE TEARDROP LABEL WAS NOT SECURE, CAUSING A STERILITY BREACH. THIS OCCURRED 12 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED THE NON PATIENT END PART TO PEN, THE GLUE IS SEPARATING FROM THE PAPER TAB AND NOT THE NEEDLE. FEELS BECAUSE ITS BEEN VERY HOT THE GLUE AND PAPER TAB PEELED AWAY FROM EACH OTHER. D C . CONSUMER STATED PRIOR TO USE, THE HUB IS FALLING APART, "ITS BROKEN" "NOT GLUED TOGETHER PROPERLY" IS THE WORDS HE USED. 12 PEN NEEDLES AFFECTED.
IT WAS REPORTED THAT 12 BD NANO¿ 2ND GEN PEN NEEDLES HAD DAMAGED HUBS THAT WERE "NOT GLUED TOGETHER PROPERLY" AND "FALLING APART". THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER STATED PRIOR TO USE, THE HUB IS FALLING APART, "ITS BROKEN" "NOT GLUED TOGETHER PROPERLY" IS THE WORDS HE USED. THE NEEDLE IS STILL ATTACHED TO THE HUB BUT THE ISSUE IS THE HUB.
IT WAS REPORTED THAT 12 BD NANO¿ 2ND GEN PEN NEEDLES HAD DAMAGED HUBS THAT WERE "NOT GLUED TOGETHER PROPERLY" AND "FALLING APART". THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER STATED PRIOR TO USE, THE HUB IS FALLING APART, "ITS BROKEN" "NOT GLUED TOGETHER PROPERLY" IS THE WORDS HE USED. THE NEEDLE IS STILL ATTACHED TO THE HUB BUT THE ISSUE IS THE HUB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 554113 | BD NANO¿ 2ND GEN PEN NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON AND CO. | 320550 | SEE H10 | 00382903205509 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |