BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE PAK

    MDR report key: 10911419 · Received November 26, 2020

    Report

    Report Number
    9610847-2020-00381
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Date of Event
    November 3, 2020
    Report Date
    December 22, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903096801
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-11-10. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE APPLICABLE PROVIDED FINAL LOT NUMBER AND SUB-ASSEMBLY LOT NUMBERS 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, OVER THREE HUNDRED SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH MICROSCOPIC EXAMINATION, A FINE BLACK LINE WAS OBSERVED IN THE BARREL COMPONENT. THROUGH USE OF AN ALCOHOL WIPE, THE FINE BLACK LINE WAS REMOVED. THE LINE WAS IDENTIFIED AS BLACK INK FROM THE SCALE PRINTING PROCESS. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED ON ANY OF THE SAMPLES RECEIVED. IT WAS POSSIBLE THAT THIS INCIDENT RESULTED DUE TO AN IMPERFECTION WITH THE BLADE COMPONENT IN THE MANUFACTURING FACILITY; HOWEVER, FURTHER REVIEW DID NOT REVEAL ANY BLADE RELATED DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE PAK EXPERIENCED AN INCIDENT OF DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE, AND FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE IDENTIFIED DEFECTS IN SOME OF OUR BD LUER-LOK TIP 50 ML SYRINGES. THERE ARE MARKS THROUGHOUT THE SYRINGES THAT LOOK LIKE STRESS FRACTURES OR CONTAMINATION OF SOME SORT. I CAN'T TELL IF THE MARKS ARE OUTSIDE, INSIDE, OR IMBEDDED IN THE PLASTIC, BUT I WAS UNABLE TO SCRAP THEM OFF FROM THE INSIDE OR OUTSIDE OF THE SYRINGE. SYRINGE SIZE: 50 ML. ITEM 309680. LOTS 0041918 & 0041905.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0041918, MEDICAL DEVICE EXPIRATION DATE: 2025-01-31, DEVICE MANUFACTURE DATE: 2020-02-21. MEDICAL DEVICE LOT #: 0041905, MEDICAL DEVICE EXPIRATION DATE: 2025-01-31, DEVICE MANUFACTURE DATE: 2020-02-19. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER-LOK" SYRINGE BULK STERILE PHARMACY CONVENIENCE PAK EXPERIENCED AN INCIDENT OF DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE, AND FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE IDENTIFIED DEFECTS IN SOME OF OUR BD LUER-LOK TIP 50 ML SYRINGES. THERE ARE MARKS THROUGHOUT THE SYRINGES THAT LOOK LIKE STRESS FRACTURES OR CONTAMINATION OF SOME SORT. I CAN'T TELL IF THE MARKS ARE OUTSIDE, INSIDE, OR IMBEDDED IN THE PLASTIC, BUT I WAS UNABLE TO SCRAP THEM OFF FROM THE INSIDE OR OUTSIDE OF THE SYRINGE. SYRINGE SIZE: 50 ML. ITEM 309680. LOTS 0041918 & 0041905.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1374672 BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE PAK PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 309680 SEE H10 30382903096801

    Patients

    Seq Age Sex Outcome Treatment
    1