SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS
Report
- Report Number
- 1920898-2024-05005
- Event Type
- Malfunction
- Date Received
- January 11, 2024
- Report Date
- April 8, 2024
- Manufacturer
- BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949
- Product Code
- FMF
- UDI-DI
- 00382908418034
- PMA / PMN Number
- K190054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST 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. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.
CONSUMER REPORTED THAT THE RUBBER STOPPER IS DAMAGED, HE STATED THAT IT APPEARS TO MELTED IN THE BARREL. CONSUMER ALSO REPORTED THAT THE PLUNGER ROD IS DIFFICULT TO MOVE. CONSUMER DOES NOT RE-USE. CONSUMER ONLY SAVED THE SYRINGE WITH THE DAMAGED STOPPER, THE OTHER SYRINGES WERE DISCARDED. LOT #: 3030357. CATALOG #: 328418. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE - SENDING MAIL KIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1818029 | SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS | SYRINGE, PISTON | FMF | BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 | 328418 | 3030357 | 00382908418034 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |