BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50CC LL TIP CONVENIENCE PAK

    MDR report key: 11645940 · Received April 9, 2021

    Report

    Report Number
    9610847-2021-00137
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 12, 2021
    Report Date
    May 5, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903096800
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A COMPLAINT OF AN INCORRECT EXPIRATION DATE WAS RECEIVED FROM THE CUSTOMER. A PHOTO WAS PROVIDED TO AID IN THE INVESTIGATION OF THIS DEFECT. IN THE PHOTO, THE INCORRECT EXPIRATION DATE CAN BE SEEN. THE CUSTOMER COMPLAINT WAS VERIFIED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 0121938. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AN ANALYSIS OF THE ROOT CAUSE WAS CONDUCTED, WHERE IT WAS DETERMINED THAT IT WAS AN ERROR WITH THE SYSTEM BECAUSE ALL THE RECORDS HAVE THE CORRECT EXPIRATION DATE. THIS IS THE FIRST COMPLAINT FOR LABEL CONTENT INCORRECT ON MATERIAL 309680 & BATCH 0121938. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50CC LL TIP CONVENIENCE PAK HAD THE WRONG EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309680 BATCH NO: 0121938. IT WAS REPORTED WRONG EXPIRATION DATE.

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: UNKNOWN. THE PATIENT¿S DATE OF BIRTH WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER 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 · 1

    IT WAS REPORTED THAT SYRINGE 50CC LL TIP CONVENIENCE PAK HAD THE WRONG EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309680, BATCH NO: 0121938. IT WAS REPORTED WRONG EXPIRATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542535 SYRINGE 50CC LL TIP CONVENIENCE PAK PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 0121938 00382903096800

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO