BD MICRO-FINE ULTRA¿ PEN NEEDLE
Report
- Report Number
- 9616656-2022-01308
- Event Type
- Malfunction
- Date Received
- December 6, 2022
- Date of Event
- November 9, 2022
- Report Date
- January 10, 2023
- Manufacturer
- BECTON DICKINSON AND CO.
- Product Code
- FMI
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6: INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST RELATED COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT.
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: 05-JAN-2023. H6. INVESTIGATION SUMMARY: FIFTY FOUR SEALED 31G X 8MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 2060492, CAT. NO. 325108. A CLOG TEST WAS CARRIED OUT ON THIRTY SAMPLES AND NO ISSUES WERE OBSERVED. NO SAMPLES WERE RETURNED FROM LOT. NO. 2110734. 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. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.
IT WAS REPORTED THAT THE BD MICRO-FINE ULTRA¿ PEN NEEDLE WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS HAD TO PRICK HIMSELF SEVERAL TIMES, BECAUSE HE CANNOT MAKE HIS INJECTION. HE HAS TO TAKE A NEW NEEDLE.
IT WAS REPORTED THAT THE BD MICRO-FINE ULTRA¿ PEN NEEDLE WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS HAD TO PRICK HIMSELF SEVERAL TIMES, BECAUSE HE CANNOT MAKE HIS INJECTION. HE HAS TO TAKE A NEW NEEDLE.
IT WAS REPORTED THAT THE BD MICRO-FINE ULTRA¿ PEN NEEDLE WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS HAD TO PRICK HIMSELF SEVERAL TIMES, BECAUSE HE CANNOT MAKE HIS INJECTION. HE HAS TO TAKE A NEW NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314766 | BD MICRO-FINE ULTRA¿ PEN NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON AND CO. | 2060492 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |