BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES

    MDR report key: 16514702 · Received March 9, 2023

    Report

    Report Number
    3003152976-2023-00050
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 14, 2023
    Report Date
    April 25, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 21-MAR-2023. TWO SAMPLES RECEIVED FOR INVESTIGATION. UPON VISUAL EVALUATION, NO DEFECTS OR ISSUES OBSERVED. THE STOPPER IS CORRECTLY ASSEMBLED, WHEN THE SYRINGE IS DISASSEMBLED THE PLUNGER DOES NOT SHOW ANY DEFECT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2210101, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THIS ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. BREAK OUT FORCE, SUSTAINING FORCE AND SILICONE CONTENT TESTS ARE PERFORMED, RESULTS FOR LOT 2210101 ARE WITHIN SPECIFICATION LIMITS. 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. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES THE PLUNGER MOVEMENT WAS DIFFICULT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE OCCLUSION ALARM IS TRIGGERED. SUSPICION OF A PROBLEM WITH THE PET SYRINGE OF THE BATCH RATHER THAN THE PCA WHICH WORKS NORMALLY WITH OTHER BATCHES. THE TRIGGERING OF THE ALARM WOULD BE DUE TO A PROBLEM WITH THE PLUNGER NOT SLIDING PROPERLY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES THE PLUNGER MOVEMENT WAS DIFFICULT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE OCCLUSION ALARM IS TRIGGERED. SUSPICION OF A PROBLEM WITH THE PET SYRINGE OF THE BATCH RATHER THAN THE PCA WHICH WORKS NORMALLY WITH OTHER BATCHES. THE TRIGGERING OF THE ALARM WOULD BE DUE TO A PROBLEM WITH THE PLUNGER NOT SLIDING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61686 BD PLASTIPAK¿ SYRINGES PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2210101 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown