SYRINGE 20ML LL NS
Report
- Report Number
- 3003152976-2023-00508
- Event Type
- Malfunction
- Date Received
- November 21, 2023
- Date of Event
- October 31, 2023
- Report Date
- December 12, 2023
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMF
- UDI-DI
- 50382903020558
- PMA / PMN Number
- K110771
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
(B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION. ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE STOPPER IS OBSERVED TO BE INCORRECTLY ASSEMBLED ONTO THE PLUNGER ROD. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2212037, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT OCCURRED AS A RESULT OF IMPROPER ALIGNMENT OF THE PLUNGER/STOPPER TO THE BARREL DURING ASSEMBLY. A CAMERA SYSTEM IS USED IN THE ASSEMBLY MACHINE TO DETECT MISSING OR IMPROPERLY ASSEMBLED STOPPERS. IT IS LIKELY A FAILURE IN DETECTION OR REJECTION SYSTEM PREVENTED THE PRODUCT FROM BEING PROPERLY DISCARDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE.
(B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. DEVICE PROBLEM CODE: A0413 - MATERIAL SEPARATION. PATIENT PROBLEM CODE: F26 ¿ NO HEALTH CONSEQUENCES OR IMPACT.
THE PLUNGER HAS BECOME UNFIT FROM THE SYRINGE DURING USE. IN HIS STATEMENT, OUR CUSTOMER SAID THAT WHEN HE TRIED TO BLEED THE SYRINGE, THE PLUNGER BECAME MALADJUSTED. WE DID NOT RECEIVE THE FAULTY SAMPLE, ONLY A PHOTO (SEE PHOTO OF THE SYRINGE ON THE FORM). HAVE YOU HAD ANY OTHER REPORTS OF THIS PROBLEM? CAN YOU REVIEW THE DOCUMENTATION FOR THE PRODUCTIONS CONCERNED AND LET US KNOW AS SOON AS POSSIBLE WHAT YOU HAVE ANALYSED AND WHAT CORRECTIVE ACTION HAS BEEN TAKEN? PLEASE LET US KNOW WITHIN 15 DAYS THE CAUSES OF THIS NON-CONFORMITY AND THE CORRECTIVE AND PREVENTIVE ACTION TAKEN TO AVOID ANY RECURRENCE. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: DID THE PATIENT (HEALTHCARE WORKER) SUFFER ANY CLINICAL CONSEQUENCES AS A RESULT OF THIS DEFECT? NOT FILLED IN WHEN THE CUSTOMER DECLARES THE FAULT.
THE PLUNGER HAS BECOME UNFIT FROM THE SYRINGE DURING USE. IN HIS STATEMENT, OUR CUSTOMER SAID THAT WHEN HE TRIED TO BLEED THE SYRINGE, THE PLUNGER BECAME MALADJUSTED. WE DID NOT RECEIVE THE FAULTY SAMPLE, ONLY A PHOTO (SEE PHOTO OF THE SYRINGE ON THE FORM). HAVE YOU HAD ANY OTHER REPORTS OF THIS PROBLEM? CAN YOU REVIEW THE DOCUMENTATION FOR THE PRODUCTIONS CONCERNED AND LET US KNOW AS SOON AS POSSIBLE WHAT YOU HAVE ANALYSED AND WHAT CORRECTIVE ACTION HAS BEEN TAKEN? PLEASE LET US KNOW WITHIN 15 DAYS THE CAUSES OF THIS NON-CONFORMITY AND THE CORRECTIVE AND PREVENTIVE ACTION TAKEN TO AVOID ANY RECURRENCE. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: DID THE PATIENT (HEALTHCARE WORKER) SUFFER ANY CLINICAL CONSEQUENCES AS A RESULT OF THIS DEFECT? NOT FILLED IN WHEN THE CUSTOMER DECLARES THE FAULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2088728 | SYRINGE 20ML LL NS | SYRINGE, PISTON | FMF | BECTON DICKINSON | 2212037 | 50382903020558 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |