BD ULTRA-FINE¿ NANO¿ PEN NEEDLE
Report
- Report Number
- 9616656-2021-01638
- Event Type
- Malfunction
- Date Received
- January 11, 2022
- Date of Event
- December 15, 2021
- Report Date
- February 24, 2022
- Manufacturer
- BECTON DICKINSON AND CO.
- Product Code
- FMI
- UDI-DI
- 00382903205509
- PMA / PMN Number
- K162516
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2022-02-07. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (28) UNUSED 32GX4MM BD PEN NEEDLES FROM LOT# 1103568. THE CUSTOMER REPORTED LEAKAGE WHEN TAKING INJECTION, WELTS AT THE INJECTION SITE, AND UNCERTAINTY OF GETTING DOSAGE. THE RETURNED PEN NEEDLES WERE EXAMINED, THEN TESTED FOR FLOW USING A TEST PEN INJECTOR, AND IT WAS OBSERVED THAT ALL 28 SAMPLES WERE ABLE TO EXPEL PROPERLY; NO LEAKAGE WAS OBSERVED. 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 NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H10.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: H5: IMDRF ANNEX E GRID: E2403, E1720. H5: IMDRF ANNEX F GRID: F24, F11. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT 1 BD ULTRA-FINE¿ NANO¿ PEN NEEDLE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED LEAKAGE WHEN TAKING INJECTION. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.
IT WAS REPORTED THAT 1 BD ULTRA-FINE¿ NANO¿ PEN NEEDLE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED LEAKAGE WHEN TAKING INJECTION. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.
IT WAS REPORTED THAT 1 BD ULTRA-FINE¿ NANO¿ PEN NEEDLE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED LEAKAGE WHEN TAKING INJECTION. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655227 | BD ULTRA-FINE¿ NANO¿ PEN NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON AND CO. | 320550 | 1103568 | 00382903205509 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |