BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 8080164 · Received November 16, 2018

    Report

    Report Number
    1911916-2018-00658
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Date of Event
    November 1, 2018
    Report Date
    February 8, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903010332
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED DUE TO CORRECTED INFORMATION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT A BD LUER-LOK¿ SYRINGE HAD FOREIGN MATTER OCCUR 7,16 AND 13 TIMES WITH LOT#'S 7353646, 8023762 AND 8110979 RESPECTIVELY. DAMAGED SYRINGES OCCURRED 2, 5 AND 9 TIMES WITH LOT#'S 7353646, 8023762 AND 8110979 RESPECTIVELY. PRINT ISSUES OCCURRED 25, 140 AND 23 TIMES WITH LOT#'S 7353646, 8023762 AND 8110979 RESPECTIVELY. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD LUER-LOK¿ SYRINGE HAD FOREIGN MATTER OCCUR 7,16 AND 13 TIMES WITH LOT#'S 7353646, 8023762 AND 8110979 RESPECTIVELY. DAMAGED SYRINGES OCCURRED 2, 5 AND 9 TIMES WITH LOT#'S 7353646, 8023762 AND 8110979 RESPECTIVELY. PRINT ISSUES OCCURRED 25, 140 AND 23 TIMES WITH LOT#'S 7353646, 8023762 AND 8110979 RESPECTIVELY. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7353646, MEDICAL DEVICE EXPIRATION DATE: 2022-12-31, DEVICE MANUFACTURE DATE: 2017-12-19. MEDICAL DEVICE LOT #: 8023762, MEDICAL DEVICE EXPIRATION DATE: 2023-01-31, DEVICE MANUFACTURE DATE: 2018-01-23. MEDICAL DEVICE LOT #: 8110979, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30, DEVICE MANUFACTURE DATE: 2018-04-20.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD LUER-LOK¿ SYRINGE HAD FOREIGN MATTER, DAMAGE, INCLUSIONS, AND PRINT ISSUES. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921497 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10. 00382903010332

    Patients

    Seq Age Sex Outcome Treatment
    1 Other