BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML SYRINGE LUER-LOK TIP

    MDR report key: 11103439 · Received December 31, 2020

    Report

    Report Number
    1911916-2020-01162
    Event Type
    Malfunction
    Date Received
    December 31, 2020
    Date of Event
    December 2, 2020
    Report Date
    January 7, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096282
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.3. DATE OF EVENT: 12/2/2020. D.4. MEDICAL DEVICE LOT #: 9210923. D.4. MEDICAL DEVICE EXPIRATION DATE: 7/31/2024. H.4. DEVICE MANUFACTURE DATE: 9/13/2019. H.6. INVESTIGATION: ONE BLACK AND WHITE PHOTO OF A LOOSE 1ML SYRINGE WAS RECEIVED AND EVALUATED. DUE TO THE LIMITED RESOLUTION OF THE PHOTO, THE "DROPLET OF LIQUID" WAS UNCLEAR. BASED ON THE VERBATIM THE "DROPLET OF LIQUID" WAS LIKELY SILICONE. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD 1ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309628 , BATCH NO.: UNKNOWN. SYRINGE 1ML LUER-LOK STERILE, SINGLE. USE POLYCARBONATE, BD#309628, 100 SYRINGES/BOX. OUR QC DEPARTMENT HAS FOUND THAT A FEW OF THEM HAVE A SMALL DROP OF LIQUID IN THEM.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 BD 1ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309628 BATCH NO.: UNKNOWN. SYRINGE 1ML LUER-LOK STERILE, SINGLE. USE POLYCARBONATE, BD#309628, 100 SYRINGES/BOX. OUR QC DEPARTMENT HAS FOUND THAT A FEW OF THEM HAVE A SMALL DROP OF LIQUID IN THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566819 BD 1ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 9210923 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1