BD LUER-LOK¿ SYRINGE
Report
- Report Number
- 1911916-2023-00360
- Event Type
- Malfunction
- Date Received
- May 31, 2023
- Date of Event
- May 8, 2023
- Report Date
- June 2, 2023
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- FMF
- PMA / PMN Number
- K980987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 30-MAY-2023 . H6: INVESTIGATION SUMMARY IT WAS REPORTED THE PLUNGER DOES NOT COME DOWN PROPERLY. TO AID IN THE INVESTIGATION, SEVEN SAMPLES WITH NO PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SAMPLES WERE THEN TESTED FOR SUSTAINING FORCE PER IT16, WHICH IS THE FORCE APPLIED TO THE PLUNGER ROD WHILE MOVING DOWNWARDS WHEN EXPELLING THE SALINE SOLUTION, AND THE RESULTS WERE WITHIN SPECIFICATION. IT COULD BE POSSIBLE THE CUSTOMER RECEIVED PRODUCT ON THE HIGHER SIDE OF SPECIFICATION REQUIRING MORE FORCE THAN NORMAL TO MOVE THE PLUNGER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301033, LOTS 2075972, 2089509, 2152690 AND 2089501. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.
B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2075972. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027. H.4. DEVICE MANUFACTURE DATE: 16-MAR-2022. D.4. MEDICAL DEVICE LOT #: 2089509. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027. H.4. DEVICE MANUFACTURE DATE: 30-MAR-2022. D.4. MEDICAL DEVICE LOT #: 2089501. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2026. H.4. DEVICE MANUFACTURE DATE: 01-DEC-2021. D.4. MEDICAL DEVICE LOT #: 2152690. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2026. H.4. DEVICE MANUFACTURE DATE: 01-DEC-2021. H.3. 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 ONE BD LUER-LOK¿ SYRINGE EACH FROM LOTS 2075972, 2089509, 2089501, AND 2152690 HAD DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "JUST RECEIVED ANOTHER SIMILAR REPORT WHERE THE PESTLE DOES NOT COME DOWN PROPERLY, EVEN MORE FORCE HAS TO BE APPLIED TO PULL THE PESTLE DOWN THAN IN THE PREVIOUS BATCH. THE BUYER STATES THAT THIS IS THE CASE WITH THE FIRST 20 SPRAYS OF THIS BATCH. AFTER THAT, THEY STOPPED THE PROCESS."
IT WAS REPORTED THAT ONE BD LUER-LOK¿ SYRINGE EACH FROM LOTS 2075972, 2089509, 2089501, AND 2152690 HAD DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "JUST RECEIVED ANOTHER SIMILAR REPORT WHERE THE PESTLE DOES NOT COME DOWN PROPERLY, EVEN MORE FORCE HAS TO BE APPLIED TO PULL THE PESTLE DOWN THAN IN THE PREVIOUS BATCH. THE BUYER STATES THAT THIS IS THE CASE WITH THE FIRST 20 SPRAYS OF THIS BATCH. AFTER THAT, THEY STOPPED THE PROCESS.".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1131079 | BD LUER-LOK¿ SYRINGE | PISTON SYRINGE | FMF | BD MEDICAL (BD WEST) MEDICAL SURGICAL | SEE H10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |