BD LUER-LOK¿ SYRINGE
Report
- Report Number
- 1911916-2022-00793
- Event Type
- Malfunction
- Date Received
- January 4, 2023
- Date of Event
- December 14, 2022
- Report Date
- January 23, 2023
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- FMF
- PMA / PMN Number
- K980987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL? YES. D.10 RETURNED TO MANUFACTURER ON: 20-JAN-2023. H.6. INVESTIGATION SUMMARY: IT WAS REPORTED THE SYRINGES HAVE LIQUID OR OIL CONDENSATION PRESENT AT THE BOTTOM OF THE BARREL. TO AID IN THE INVESTIGATION, FOURTEEN SAMPLES IN SEALED PACKAGING BLISTERS LABELED AS "CODAN US CORP" AND THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED TO EACH SAMPLE WITH A 10X MAGNIFIER LENS, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE LUBRICATION TO THE STOPPER AND SYRINGE BARREL LOOKS NORMAL. THE PHOTOS SHOW A SYRINGE CONNECTED TO A PLASTIC LINE. THE BOTTOM OF THE SYRINGE BARREL HAS VISIBLE RESIDUES OF LUBRICANT. THE LUBRICANT IS MEDICAL GRADE AND APPLIED TO THE INNER WALL OF THE SYRINGE BARREL AND RUBBER STOPPER TO MAKE THE MOVEMENT OF THE PLUNGER SMOOTHER IN THE SYRINGE BARREL. WHAT IS DEMONSTRATED IN THE PHOTOS IS ACCEPTABLE AS LUBRICANT IS A NORMAL MATERIAL USED IN THE MANUFACTURING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301033, LOT NUMBERS 1113451 AND 1113460. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THESE LOTS. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1113451, MEDICAL DEVICE EXPIRATION DATE: 2026-04-30, DEVICE MANUFACTURE DATE: 2021-04-23. MEDICAL DEVICE LOT #: 1113460, MEDICAL DEVICE EXPIRATION DATE: 2026-04-30, DEVICE MANUFACTURE DATE: 2021-04-23. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY: IT WAS REPORTED THE SYRINGES HAVE LIQUID OR OIL CONDENSATION PRESENT AT THE BOTTOM OF THE BARREL. TO AID IN THE INVESTIGATION, THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A SYRINGE CONNECTED TO A PLASTIC LINE. THE BOTTOM OF THE SYRINGE BARREL HAS VISIBLE RESIDUES OF LUBRICANT. THE LUBRICANT IS MEDICAL GRADE AND APPLIED TO THE INNER WALL OF THE SYRINGE BARREL AND RUBBER STOPPER TO MAKE THE MOVEMENT OF THE PLUNGER SMOOTHER IN THE SYRINGE BARREL. WHAT IS DEMONSTRATED IN THE PHOTOS IS ACCEPTABLE AS LUBRICANT IS A NORMAL MATERIAL USED IN THE MANUFACTURING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301033, LOT NUMBERS 1113451 AND 1113460. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THESE LOTS. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD LUER-LOK¿ SYRINGES EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVIDENCE OF LQUID/OIL CONDENSATION ARE PRESENT IN THE BOTTOM BARREL.
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD LUER-LOK¿ SYRINGES EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVIDENCE OF LQUID/OIL CONDENSATION ARE PRESENT IN THE BOTTOM BARREL.
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD LUER-LOK¿ SYRINGES EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVIDENCE OF LQUID/OIL CONDENSATION ARE PRESENT IN THE BOTTOM BARREL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1391140 | BD LUER-LOK¿ SYRINGE | PISTON SYRINGE | FMF | BD MEDICAL (BD WEST) MEDICAL SURGICAL | SEE H10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |