LUER-LOK
Report
- Report Number
- 3003152976-2025-00076
- Event Type
- Malfunction
- Date Received
- March 4, 2025
- Date of Event
- February 13, 2025
- Report Date
- August 1, 2025
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMF
- UDI-DI
- 00382903008650
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.
(B)(6) - SUPPLEMENTAL MDR - FOREIGN MATTER. A REVIEW OF TWO SUBMITTED PHOTOGRAPHS REVEALED A BLACK PARTICULATE SUSPENDED IN A TRANSPARENT FLUID WITHIN A NON-BD CONTAINER, WITH THE SECOND IMAGE SHOWING THE PARTICULATE MEASURED VIA A VISION SYSTEM. HOWEVER, BASED SOLELY ON THESE IMAGES, IT IS NOT POSSIBLE TO CONFIRM WHETHER THE DEFECT ORIGINATED FROM THE MANUFACTURING SITE. FOR A THOROUGH EVALUATION, EITHER A PHYSICAL, UNUSED BD SAMPLE EXHIBITING THE REPORTED DEFECT OR A CLEAR PHOTOGRAPH SHOWING THE DEFECT ON A BD PRODUCT IS REQUIRED. ADDITIONALLY, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR THE PROVIDED LOT NUMBER 4052766, WHICH SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED IN TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA TO IDENTIFY ANY EMERGING TRENDS.
(B)(6). FOLLOW UP MDR FOR DEVICE EVALUATION: TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON REVIEW, A PARTICLE WAS OBSERVED, HOWEVER, THE DEVICE SHOWN DOES NOT CORRESPOND TO EITHER OF THE POTENTIAL MATERIALS REPORTED OR ANY DEVICE MANUFACTURED AT OUR FACILITY. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR POTENTIAL LOT 2401097, ASSOCIATED WITH MATERIAL 300629, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS RELATED TO THE REPORTED EVENT. RETAINED SAMPLES OF MATERIAL 300629, LOT 2401097 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCTS WERE VISUALLY INSPECTED; NO FOREIGN MATTER OR OTHER CONTAMINATION WAS OBSERVED ON ANY OF THE DEVICES. AS A LOT FOR POTENTIAL PRODUCT 300865 WAS NOT AVAILABLE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED AND RETAINED SAMPLES COULD NOT BE EVALUATED. BASED ON THE AVAILABLE INFORMATION, A ROOT CAUSE RELATED TO OUR DEVICE OR MANUFACTURING PROCESS CANNOT BE ESTABLISHED AT THIS TIME. COMPLAINTS RECEIVED FOR THE SUSPECTED DEVICES AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
(B)(4) FOLLOW UP REPORT FOR CORRECTION. CATALOG NUMBER WAS INCORRECT IN THE INITIAL MDR. CORRECT CATALOG NUMBER FOR PRODUCT IS 300912. LOT NUMBER WAS INCORRECT IN THE INITIAL MDR. CORRECT CATALOG NUMBER FOR PRODUCT IS 4052766.
DESCRIPTION/EVENT DETAILS: DURING THE PROCESSING OF A SOLUTION, A POLYPROPYLENE PARTICLE WITH A DIAMETER OF APPROXIMATELY 1.3 MM WAS FOUND IN A SAMPLE. UNKNOWN SYRINGE.
NO ADDITIONAL INFORMATION WAS PROVIDED.
NO ADDITIONAL INFORMATION
CATALOG NUMBER WAS INCORRECT IN THE INITIAL MDR. CORRECT CATALOG NUMBER FOR PRODUCT IS 300912. LOT NUMBER WAS INCORRECT IN THE INITIAL MDR. CORRECT CATALOG NUMBER FOR PRODUCT IS 4052766.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1344822 | LUER-LOK | SYRINGE, PISTON | FMF | BECTON DICKINSON | 4052766 | 00382903008650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |