BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA

    MDR report key: 10709332 · Received October 20, 2020

    Report

    Report Number
    3002682307-2020-00319
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    September 27, 2020
    Report Date
    November 16, 2020
    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 · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL YES. RETURNED TO MANUFACTURER ON: 2020-11-11. INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1902153 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, BOTH PICTURE AND PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PHYSICAL SAMPLE, THE CANNULA WAS OBSERVED RUSTED. IT HAS BEEN DETERMINED THAT THIS INCIDENT MOST LIKELY RESULTED FROM INCORRECT STORAGE OF THE PRODUCT. THIS TYPE OF DEFECT MAY RESULT IF THE PRODUCT IS STORED CLOSE TO DETERGENTS AND CLEANING PRODUCT SUBSTANCES LIKE SODIUM HYPOCHLORITE OR SIMILAR PRODUCTS. OUR QUALITY TEAM WILL CLOSELY MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA HAD FOREIGN MATTER ON 2 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2020, THE TEACHER OF THE SIXTH DEPARTMENT OF CARDIOLOGY OF THE (B)(6) UNIVERSITY OPENED THE PACKAGE AND WAS PREPARING TO USE THE BD10ML SYRINGE FOR DISPENSING AND FOUND THAT THE NEEDLE HAD A BLACK SPOT SIMILAR TO "RUST".

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA HAD FOREIGN MATTER ON 2 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2020, THE TEACHER OF (B)(6) OPENED THE PACKAGE AND WAS PREPARING TO USE THE BD10ML SYRINGE FOR DISPENSING AND FOUND THAT THE NEEDLE HAD A BLACK SPOT SIMILAR TO "RUST".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173698 SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other