BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES NON-STERILE

    MDR report key: 17222060 · Received June 28, 2023

    Report

    Report Number
    3003152976-2023-00261
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    June 6, 2023
    Report Date
    July 17, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2101083, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. 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, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED DURING MANUFACTURING. BASED ON THE AVAILABLE INFORMATION WE CANNOT IDENTIFY A ROOT CAUSE AT THIS TIME.

    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 NON-STERILE THE PRODUCT WAS CRACKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT NO. 300220. LOT NO. 2101083. QUANTITY REPORTED - 1. COMPLAINT ISSUE ¿ LONGITUDINAL CRACK ON THE SIDE OF THE SYRINGE. NO SAMPLE PHOTOGRAPH.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES NON-STERILE THE PRODUCT WAS CRACKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT NO. 300220. LOT NO. 2101083. QUANTITY REPORTED - 1. COMPLAINT ISSUE ¿ LONGITUDINAL CRACK ON THE SIDE OF THE SYRINGE. NO SAMPLE PHOTOGRAPH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308514 BD PLASTIPAK¿ SYRINGES NON-STERILE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2101083

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown