BD LUER-LOK¿ DISPOSABLE SYRINGE
Report
- Report Number
- 1213809-2018-00366
- Event Type
- Malfunction
- Date Received
- June 13, 2018
- Date of Event
- April 2, 2018
- Report Date
- August 24, 2018
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903096283
- PMA / PMN Number
- K980987
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
INVESTIGATION SUMMARY: ONE LOOSE 1ML ASSEMBLED SYRINGE WAS RECEIVED BY BD CANAAN AND REPORTED TO BE FROM BATCH #7082993 (P/N 309628). THE SAMPLE WAS VISUALLY EVALUATED. THE BARREL WAS OBSERVED TO HAVE NUMEROUS BLACK SPECS THROUGHOUT THE BARREL. THE SPECS APPEAR TO BE EMBEDDED IN THE BARREL. THE BARREL WAS FOUND TO HAVE EMBEDDED FOREIGN MATTER. THE FOREIGN MATTER WAS SMALL BLACK DOTS THROUGHOUT THE ENTIRETY OF THE BARREL. THE SAMPLE ALSO HAS SCUFFS / MARKS ON THE BARREL NEAR THE 0.2 GRADLINE, IT WAS NOT CLEAR IF THIS WAS CAUSED FROM THE BARREL BEING CUT OR WAS PRESENT PRIOR TO THAT. DHR REVIEW FOR BATCH 7082993 (P/N 309628): MANUFACTURING DATES: 04/04/2017 ¿ 04/05/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. A WATER LEAK WAS RECORDED IN ONE OF THE MOLDING MACHINES MANUFACTURING THE BARRELS FOR THIS PRODUCT. THE MACHINE WAS DOWN FOR APPROXIMATELY 4 HOURS TO ADDRESS THE PROBLEM BEFORE PRODUCTION RESUMED. BATCH 7082993 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. INVESTIGATION CONCLUSION: THE DEFECT OBSERVED WAS IDENTIFIED AS OVER PROCESSED PLASTIC DUE TO ELEVATED TEMPERATURE INSIDE THE MOLDING MACHINE, SUCH AS DURING START UP. IT IS POSSIBLE THAT SOME OF THE DEGRADED PLASTIC REMAINS INSIDE THE MOLD¿S MANIFOLD AND MAY BECOME DISLODGED AFFECTING A LIMITED NUMBER OF BARRELS. THIS CONDITION IS ATTRIBUTED IN PART TO THE INCONSISTENT FREQUENCY OF MOLD MANIFOLD CLEANING. THE OVERALL DEFECTIVE RATE REMAINS LOW BASED ON THE NUMBER OF COMPLAINTS AND DEFECTIVE PARTS RECEIVED FOR BATCH 7082993. CORRECTIVE ACTIONS: (1) MANIFOLD CLEANING FREQUENCY WAS RECENTLY INCREASED AS A PREVENTIVE MEASURE FOR EMBEDDED FOREIGN MATTER SIMILAR TO THE DEFECT OBSERVED IN THE SAMPLE RECEIVED. THE MOST RECENT MANIFOLD CLEANING FOR THIS MOLD WAS PERFORMED IN (B)(6) 2018. (2) THE MANIFOLD CLEANING WAS ADDED TO THE PREVENTIVE MAINTENANCE PLAN OF THE MOLD.
CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE: YES.
IT WAS REPORTED THAT BEFORE USE A BD LUER-LOK¿ DISPOSABLE SYRINGE WAS FOUND WITH FOREIGN MATTER AS ¿ THE PHYSICIAN WENT TO DO AN INJECTION OF EYLEA BUT NOTICED DEBRIS THAT LOOKED LIKE PAINT IN THE SYRINGE." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.
IT WAS REPORTED THAT BEFORE USE A BD LUER-LOK¿ DISPOSABLE SYRINGE WAS FOUND WITH FOREIGN MATTER AS ¿ THE PHYSICIAN WENT TO DO AN INJECTION OF EYLEA BUT NOTICED DEBRIS THAT LOOKED LIKE PAINT IN THE SYRINGE." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT BEFORE USE A BD LUER-LOK¿ DISPOSABLE SYRINGE WAS FOUND WITH FOREIGN MATTER AS ¿ THE PHYSICIAN WENT TO DO AN INJECTION OF EYLEA BUT NOTICED DEBRIS THAT LOOKED LIKE PAINT IN THE SYRINGE." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 437275 | BD LUER-LOK¿ DISPOSABLE SYRINGE | SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 7082993 | 30382903096283 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |