BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL S/C 200

    MDR report key: 12847320 · Received November 19, 2021

    Report

    Report Number
    1213809-2021-00775
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    October 21, 2021
    Report Date
    November 3, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE DISASSEMBLED 10ML SYRINGE WAS RECEIVED (P/N 302995). THE SAMPLE WAS VISUALLY EVALUATED. NO VISUAL DEFECTS WERE OBSERVED WITH THE BARREL OR ITS RETAINING RING. THE STOPPER WAS OBSERVED TO BE LOOSE ON THE PLUNGER HEAD, WHICH COULD CONTRIBUTE TO THE DISLODGING OF THE PLUNGER. WHEN THE STOPPER WAS REMOVED THE PLUNGER'S HEAD WAS VISIBLY MISSHAPEN (SQUARE HEADED). THE PLUNGER WAS NON-CONFORMING CONDITION PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE SQUARE PLUNGER HEAD DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH #1210862 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: POTENTIAL ROOT CAUSE FOR THE SQUARE PLUNGER HEAD DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE AQL FOR SQUARE PLUNGER HEADS IS (B)(4)%. THE DEFECTIVE RATE IDENTIFIED IS (B)(4)%. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH #1210862 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE DISASSEMBLED 10ML SYRINGE WAS RECEIVED (P/N (B)(4)). THE SAMPLE WAS VISUALLY EVALUATED. NO VISUAL DEFECTS WERE OBSERVED WITH THE BARREL OR ITS RETAINING RING. THE STOPPER WAS OBSERVED TO BE LOOSE ON THE PLUNGER HEAD, WHICH COULD CONTRIBUTE TO THE DISLODGING OF THE PLUNGER. WHEN THE STOPPER WAS REMOVED THE PLUNGER'S HEAD WAS VISIBLY MISSHAPEN (SQUARE HEADED). THE PLUNGER WAS NON-CONFORMING CONDITION PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE SQUARE PLUNGER HEAD DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH #1210862 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: POTENTIAL ROOT CAUSE FOR THE SQUARE PLUNGER HEAD DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE AQL FOR SQUARE PLUNGER HEADS IS 0.65%. THE DEFECTIVE RATE IDENTIFIED IS 1 OUT OF 488,000 WHICH IS 0.0002%. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH #1210862 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE BD SYRINGE 10ML LL S/C 200 EXPERIENCED A LOOSE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LOBOTOMIST WAS USING A SYRINGE AND THE PLUNGER DISLODGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE BD SYRINGE 10ML LL S/C 200 EXPERIENCED A LOOSE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LOBOTOMIST WAS USING A SYRINGE AND THE PLUNGER DISLODGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744957 BD SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 302995 1210862 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown