BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ INSULIN SYRINGE WITH BD¿ PERMANENTLY ATTACHED NEEDLE

    MDR report key: 7566929 · Received June 4, 2018

    Report

    Report Number
    1920898-2018-00401
    Event Type
    Malfunction
    Date Received
    June 4, 2018
    Date of Event
    May 16, 2018
    Report Date
    July 11, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED A PHOTO OF A 1/2CC, 13MM, 29G BD SAFETYGLIDE INSULIN SYRINGE FROM CAT # 305932 IN A SEALED BLISTER PACK WITH THE SHIPPING CARTON FROM LOT # 8002686. CUSTOMER STATES THAT THE BOX READ 1ML AND THE INDIVIDUAL SYRINGES INSIDE THE BOX READ 1/2ML. THE ATTACHED PHOTO WAS EXAMINED AND EXHIBITED THE LABEL ON THE SHIPPING CARTON INCORRECTLY IDENTIFIED THE PRODUCT AS 1CC SYRINGES FROM CAT # 350930. SEE ATTACHED PHOTOS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8002686. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. NOTE: WHILE DOING THE DHR REVIEW IT WAS OBSERVED THAT THE WRONG LABEL (CATALOG # 305930) WAS FOUND TO BE IN WITH THE LABEL RETAINS OF CATALOG #305932. A ZM WAS WRITTEN [200753519]. THERE WERE TWO (2) NOTIFICATIONS [200735281, 200735618] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THIS ISSUE. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. INVESTIGATION CONCLUSION: CAPA (B)(4) AND SA BDDC-18-1288 WERE INITIATED BY THE HOLDREGE PLANT TO ADDRESS THIS LOT AND EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH BD¿ PERMANENTLY ATTACHED NEEDLE THERE WAS AN ISSUE WITH LABELING ERROR. IT WAS STATED ¿THE BOX READ 1ML AND THE INDIVIDUAL SYRINGES INSIDE THE BOX READ 1/2ML.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT # DOES NOT EXIST FOR THE REPORTED CAT #. THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER PHONE#: (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH BD¿ PERMANENTLY ATTACHED NEEDLE THERE WAS AN ISSUE WITH LABELING ERROR. IT WAS STATED ¿THE BOX READ 1ML AND THE INDIVIDUAL SYRINGES INSIDE THE BOX READ 1/2ML.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409272 BD SAFETYGLIDE¿ INSULIN SYRINGE WITH BD¿ PERMANENTLY ATTACHED NEEDLE INSULIN SYRINGE AND NEEDLE MEG BD MEDICAL - DIABETES CARE 8002686

    Patients

    Seq Age Sex Outcome Treatment
    1 Other