BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALLERGY TRAY SAFETYGLIDE

    MDR report key: 16515721 · Received March 9, 2023

    Report

    Report Number
    1920898-2023-00105
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 14, 2023
    Report Date
    August 24, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    UDI-DI
    00382903059508
    PMA / PMN Number
    K992734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. ONE PHOTO OF UNOPENED SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 PACKAGE AND OTHER TWO PHOTOS WITH INSULIN AND ALLERGY SYRINGES. IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE BEEN RECEIVING TRAYS THAT SHOULD HAVE ALLERGY SYRINGES BUT WILL OCCASIONALLY FIND INSULIN SYRINGES MIXED IN THE TRAY. THE IMAGES PROVIDED SHOWS BOTH INSULIN AND ALLERGY SYRINGES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2101496. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. AFTER THOROUGH INVESTIGATION, IT CAN BE CONCLUDED THAT, THERE IS A POSSIBILITY OF PREVIOUS THE WIP (WORK IN PROCESS) PRODUCT FROM THE PRINT SCALE# SM700167 WAS LEFT OVER FROM PRECEDENT BATCHES MANUFACTURED. DUE TO INADEQUATE ADHERENCE TO LOCAL PROCEDURE HN11024 ¿ PRODUCT IDENTIFICATION, INCORRECT WIP PRODUCT COULD HAVE INADVERTENTLY BEEN INTRODUCED INTO THE PRODUCT FLOW. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2221315. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2027. DEVICE MANUFACTURE DATE: 09-AUG-2022. MEDICAL DEVICE LOT #: 2101496. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2027. DEVICE MANUFACTURE DATE: 11-APR-2022

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY RECEIVED 81 OF THE BD ALLERGY TRAY SAFETYGLIDE WITH 1-3 INSULIN SYRINGES MIXED IN THE TRAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEEN RECEIVING TRAYS THAT SHOULD CONTAIN ALLERGY SYRINGES BUT WILL OCASIONALLY FIND 1-3 INSULIN SYRINGES MIXED IN THE TRAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY RECEIVED 81 OF THE BD ALLERGY TRAY SAFETYGLIDE WITH 1-3 INSULIN SYRINGES MIXED IN THE TRAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEEN RECEIVING TRAYS THAT SHOULD CONTAIN ALLERGY SYRINGES BUT WILL OCASIONALLY FIND 1-3 INSULIN SYRINGES MIXED IN THE TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121185 BD ALLERGY TRAY SAFETYGLIDE SYRINGE, ANTISTICK MEG BD MEDICAL - DIABETES CARE SEE H.10 00382903059508

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown