BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LS 22X1-1/4 AN EMERALD

    MDR report key: 12089659 · Received June 29, 2021

    Report

    Report Number
    3002682307-2021-00289
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    April 17, 2021
    Report Date
    June 28, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER: BD WAS INITIALLY MADE AWARE OF THIS COMPLAINT ON (B)(6) 2021. AT THAT TIME, BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER, IT WAS EVALUATED AS A NON-REPORTABLE INCIDENT. ADDITIONAL INFORMATION WAS LATER RECEIVED ON (B)(6) 2021 THAT CHANGED THE REPORTABILITY DETERMINATION. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THIS COMPLAINT IS NOW CONSIDERED TO BE AN MDR REPORTABLE INCIDENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1901131 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR EVALUATION. THE RETAINED SAMPLES WERE EXAMINED AND NO SIGNS OF DEFECT WERE OBSERVED. THE MATERIAL USED TO MANUFACTURE THE EMERALD SYRINGE HAS BEEN SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. THE ASSEMBLY MACHINES HAVE AN IN-LINE DETECTION SYSTEM THAT INSPECTS ALL PRODUCT AND AUTOMATICALLY REJECTS PRODUCT WITH SIGNS OF DEFECT. INVESTIGATION CONCLUSION: FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS. ROOT CAUSE DESCRIPTION: BASED ON THESE PREVENTIVE MEASURES, WE BELIEVE THIS INCIDENT WAS A CONSEQUENCE OF STORAGE CONDITIONS DURING MANUFACTURING. IF THE BARREL IS STILL HOT WHEN THE PRODUCT IS STORED, IT MAY BECOME DAMAGED OR BENT. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. RATIONALE: WE CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS AN ISOLATED ISSUE AND ANY RECURRENCE IS REALLY UNLIKELY IN OUR PRODUCTS SINCE REVIEW SYRINGE DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT, CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION, NO ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 5ML LS 22X1-1/4 AN EMERALD TIP WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER INTRAMUSCULAR INJECTION OF OXYTOCIN FOR THE PATIENT, THE TIP OF THE 5ML SYRINGE WAS FOUND BENT WHEN EXTRACTING THE LIQUID, SO THE SYRINGE WAS REPLACED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985615 SYRINGE 5ML LS 22X1-1/4 AN EMERALD SYRINGE FMF BECTON DICKINSON, S.A. 1901131

    Patients

    Seq Age Sex Outcome Treatment
    1