BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL TIP CONV PAK

    MDR report key: 11507757 · Received March 17, 2021

    Report

    Report Number
    9610847-2021-00103
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 19, 2021
    Report Date
    March 26, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903056187
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 0182698. 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. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THIS IS THE FIRST COMPLAINT FOR FOREIGN MATTER ON MATERIAL 305618 & BATCH 0182698. 0

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 30ML LL TIP CONV PAK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305618, BATCH NO: 0182698   IT WAS REPORTED THAT IN TWO SEPARATE PACKS OF THE SYRINGES, CONTAMINANTS WERE FOUND WITHIN THE STERILE PACK UPON OPENING THE PACK.   VERBATIM: IN TWO SEPARATE PACKS OF THE SYRINGES, CONTAMINANTS WERE FOUND WITHIN THE STERILE PACK UPON OPENING THE PACK. ONE PACK HAD A 1 CM SIZE PIECE OF WHAT LOOKED LIKE BROWN CORRUGATED CARDBOARD AND ONE PACK HAD A PIECE OF BLACK HAIR WITHIN THE PACK. BOTH OF THESE PACKS WERE USED IN AN ISO 5 ENVIRONMENT AND OPENED BY A TECHNICIAN FULLY GARBED IN PPE. FINDING THE CONTAMINANTS FORCED US TO WASTE THE MEDICATIONS THAT WERE BEING COMPOUNDED.

    Additional Manufacturer Narrative · 1

    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 30ML LL TIP CONV PAK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305618, BATCH NO: 0182698.   IT WAS REPORTED THAT IN TWO SEPARATE PACKS OF THE SYRINGES, CONTAMINANTS WERE FOUND WITHIN THE STERILE PACK UPON OPENING THE PACK.   VERBATIM: IN TWO SEPARATE PACKS OF THE SYRINGES, CONTAMINANTS WERE FOUND WITHIN THE STERILE PACK UPON OPENING THE PACK. ONE PACK HAD A 1 CM SIZE PIECE OF WHAT LOOKED LIKE BROWN CORRUGATED CARDBOARD AND ONE PACK HAD A PIECE OF BLACK HAIR WITHIN THE PACK. BOTH OF THESE PACKS WERE USED IN AN ISO 5 ENVIRONMENT AND OPENED BY A TECHNICIAN FULLY GARBED IN PPE. FINDING THE CONTAMINANTS FORCED US TO WASTE THE MEDICATIONS THAT WERE BEING COMPOUNDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405007 SYRINGE 30ML LL TIP CONV PAK PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 0182698 00382903056187

    Patients

    Seq Age Sex Outcome Treatment
    1