BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES

    MDR report key: 16959283 · Received May 18, 2023

    Report

    Report Number
    3003152976-2023-00185
    Event Type
    Malfunction
    Date Received
    May 18, 2023
    Date of Event
    March 19, 2023
    Report Date
    July 27, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 11JUL2023. H6: INVESTIGATION SUMMARY: ONE SAMPLE RECEIVED FOR INVESTIGATION. UPON VISUAL EVALUATION, THE PLUNGER IS NOT BROKEN, IT WAS OBSERVED THAT THE STOPPER WAS INCORRECTLY ASSEMBLED TO THE PLUNGER, DISTORTED AGAINST THE BARREL WALL. DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2211122, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THIS ISSUE WAS DETERMINED TO HAVE OCCURRED AS A RESULT OF IMPROPER ALIGNMENT OF THE PLUNGER/STOPPER TO THE BARREL DURING ASSEMBLY. 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. THE AREA MANAGER HAS BEEN MADE AWARE OF YOUR EXPERIENCE TO INCREASE AWARENESS OF THIS MATTER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES THE PLUNGER WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE DETAILS OF THE INCIDENT ARE AS FOLLOWS, "DURING AN EMERGENCY SITUATION, I REALIZE THAT THE PLUNGER ON THE SYRINGE IS DEFECTIVE. I HAVE TO START MY PREPARATION OVER, WHICH REPRESENTS A LOSS OF TIME FOR THE PATIENT'S CARE." THE CONSEQUENCES FOR THE PATIENT ARE AS FOLLOWS: DELAY IN CARE THIS INCIDENT WAS NOT REPORTED TO THE ANSM. WE HAVE RECOVERED THE INCRIMINATED DEVICE TO SEND IT TO YOU FOR EXPERTISE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES THE PLUNGER WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE DETAILS OF THE INCIDENT ARE AS FOLLOWS, "DURING AN EMERGENCY SITUATION, I REALIZE THAT THE PLUNGER ON THE SYRINGE IS DEFECTIVE. I HAVE TO START MY PREPARATION OVER, WHICH REPRESENTS A LOSS OF TIME FOR THE PATIENT'S CARE." THE CONSEQUENCES FOR THE PATIENT ARE AS FOLLOWS: DELAY IN CARE. THIS INCIDENT WAS NOT REPORTED TO THE ANSM. WE HAVE RECOVERED THE INCRIMINATED DEVICE TO SEND IT TO YOU FOR EXPERTISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016416 BD PLASTIPAK¿ SYRINGES PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2211122 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown