PEN NDL 32G 4MM 100BX 1200 USA
Report
- Report Number
- 9616656-2024-05098
- Event Type
- Malfunction
- Date Received
- February 16, 2024
- Report Date
- May 10, 2024
- Manufacturer
- BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND
- Product Code
- FMI
- UDI-DI
- 00382903201228
- PMA / PMN Number
- K213478
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
H3 OTHER TEXT : DEVICE NOT AVAILABLE.
INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 2ND 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.
CONSUMER REPORTED FINDING THE NEEDLE TO CLOG DURING FLOW CHECK. LOT # 3032930 & 2033596. CATALOG# 320122. DATE OF EVENT UNKNOWN - THE PAST MONTHS TIME FOUND (B)(4) PEN NEEDLES FROM THE 2N BOXES. SAMPLE STATUS DISCARD - (B)(6). (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 386659 | PEN NDL 32G 4MM 100BX 1200 USA | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND | 320122 | 3032930 | 00382903201228 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |