BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G
Report
- Report Number
- 2243072-2021-03023
- Event Type
- Malfunction
- Date Received
- January 4, 2022
- Date of Event
- December 6, 2021
- Report Date
- March 10, 2022
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMI
- UDI-DI
- 10885403928659
- PMA / PMN Number
- K933545
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
DATE OF EVENT: UNKNOWN. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NO INSULIN FLOW. D2: MEDICAL DEVICE BRAND NAME: BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G D2: COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE D4: UDI # (B)(6) G.5. PMA / 510(K)#: K933545 D4: MEDICAL DEVICE LOT #: 7264659 D4: MEDICAL DEVICE EXPIRATION DATE: 2023-11-30 H4: DEVICE MANUFACTURE DATE: 2017-11-10 D4: MEDICAL DEVICE LOT #: 7291740 D4: MEDICAL DEVICE EXPIRATION DATE: 2023-12-31 H4: DEVICE MANUFACTURE DATE: 2017-12-06 D4: MEDICAL DEVICE LOT #: 9121958 D4: MEDICAL DEVICE EXPIRATION DATE: 2024-04-30 H4: DEVICE MANUFACTURE DATE: 2019-05-01 D4: MEDICAL DEVICE LOT #: 9268398 D4: MEDICAL DEVICE EXPIRATION DATE: 2024-09-30 H4: DEVICE MANUFACTURE DATE: 2019-09-25 D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2022-02-07 H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (20) USED 32GX4MM BD PEN NEEDLES (4 FROM LOT# 7264659, 8 FROM LOT# 7291740, 4 FROM LOT# 9121958, 4 FROM LOT# 9268398). THE CUSTOMER REPORTED NO INSULIN FLOW AND THAT THE PATIENT END NEEDLE WAS BENT. THE RETURNED SAMPLES WERE EXAMINED, AND IT WAS OBSERVED THAT ALL 20 RETURNED PEN NEEDLES EXHIBITED A BENT NON-PATIENT END (NPE) CANNULA. NONE OF THE RETURNED PEN NEEDLES EXHIBITED A BENT/DAMAGED PATIENT END (PE) CANNULA. THE BENT NPE CANNULAS WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLES. SINCE THE SAMPLES WERE RETURNED AFTER USE, THE PROBABLE CAUSE OF THE BENT NPE CANNULAS IS USER RELATED. 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. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (NPE CANNULA BENT). THE ROOT CAUSE FOR THIS ISSUE IS USER RELATED. THE NPE CANNULAS WERE BENT BY THE USER AFTER HANDLING THE PEN NEEDLES.
H6: INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. NO DHR REVIEW CAN BE CARRIED OUT AS LOT NUMBER IS UNKNOWN. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT THE UNSPECIFIED BD PEN NEEDLE WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NO INSULIN FLOW.
IT WAS REPORTED THAT THE UNSPECIFIED BD PEN NEEDLE WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NO INSULIN FLOW.
IT WAS REPORTED THAT THE BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NO INSULIN FLOW.
IT WAS REPORTED THAT THE UNSPECIFIED BD PEN NEEDLE WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NO INSULIN FLOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1270623 | BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON | 2865 | SEE H10 | 10885403928659 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |