BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LS 21X1-1/2 DN INDIA BP

    MDR report key: 9252448 · Received October 29, 2019

    Report

    Report Number
    2243072-2019-02411
    Event Type
    Malfunction
    Date Received
    October 29, 2019
    Date of Event
    October 14, 2019
    Report Date
    October 30, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF ¿CHEMOTHERAPY DRUGS ARE LEAKING FROM THE BARREL WHILE PULLING THE PLUNGER. THAT IS LEADING TO THE DRUG LOSS¿ WITH LOT NUMBER 9211401 AND 9211402 REGARDING ITEM # 303080 SO THE COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. THE TEAM INVESTIGATED AND CONFIRMED THE DIMENSION OF THE NOZZLE OF THE RETENTION SAMPLES FOR THE LOT NUMBER 9211402 AND FOUND WITHIN THE SPECIFICATION LIMIT. ALSO FUNCTIONAL TESTING WAS PERFORMED WITH NEEDLE AND NO LEAKAGE WAS OBSERVED. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED THAT BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED FAILURE. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD¿ SYRINGE 10ML LS 21X1-1/2 DN INDIA BP LEAKED A CHEMOTHERAPY DRUG FROM THE BARREL WHILE PULLING THE PLUNGER. THIS OCCURRED ON 50 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CHEMOTHERAPY DRUGS ARE LEAKING FROM THE BARREL WHILE PULLING THE PLUNGER. THAT IS LEADING TO THE DRUG LOSS.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9211402. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. DEVICE MANUFACTURE DATE: 2019-07-30. MEDICAL DEVICE LOT #: 9211401. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. DEVICE MANUFACTURE DATE: 2019-07-30. 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 · 1

    IT WAS REPORTED THAT DURING USE OF THE BD¿ SYRINGE 10ML LS 21X1-1/2 DN INDIA BP LEAKED A CHEMOTHERAPY DRUG FROM THE BARREL WHILE PULLING THE PLUNGER. THIS OCCURRED ON 50 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CHEMOTHERAPY DRUGS ARE LEAKING FROM THE BARREL WHILE PULLING THE PLUNGER. THAT IS LEADING TO THE DRUG LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047937 BD SYRINGE 10ML LS 21X1-1/2 DN INDIA BP SYRINGE FMF BECTON DICKINSON SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other