BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH SAFETYGLIDE¿ WITH NEEDLE

    MDR report key: 7580568 · Received June 7, 2018

    Report

    Report Number
    1920898-2018-00426
    Event Type
    Malfunction
    Date Received
    June 7, 2018
    Date of Event
    May 18, 2018
    Report Date
    July 11, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    UDI-DI
    30382903059035
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED ((B)(4)) 1/2CC, 13MM, 29G BD SAFETYGLIDE INSULIN SYRINGES IN SEALED BLISTER PACKS IN SHIPPING CARTONS FROM LOT # 8002686. CUSTOMER STATES THAT THE PRODUCT IS LABELED INCORRECTLY ON THE OUTSIDE LABEL. THE RETURNED SHIPPING CARTONS AND PHOTOS WERE EXAMINED AND THE OUTER PLASTIC WRAP HAD A LABEL CORRECTLY IDENTIFYING THE PRODUCT AS 1/2CC SYRINGES FROM CAT # 305932. HOWEVER, THE LABEL ON THE SHIPPING CARTON INCORRECTLY IDENTIFIED THE PRODUCT AS 1CC SYRINGES FROM CAT # 350930. 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 REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8002686. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT FOR MIXED PRODUCT ON LOT # 8002686. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. MANUFACTURING (HOLDREGE) WAS NOTIFIED OF THIS ISSUE, AND PERFORMED AN ANALYSIS. ON (B)(6) 2018, PHOTOGRAPHS PROVIDED FOR PR412686 WERE EVALUATED BY HOLDREGE WITH THE FOLLOWING FINDING(S): CUSTOMER PROVIDED PHOTOGRAPHS OF THE CARTON LABEL DEPICTING THAT THE PRODUCT WITHIN THE CARTON WAS CATALOG# 305930 / BATCH# 8002686. ALSO NOTED WITHIN THE PHOTOS, ONE (1) OF THE INDIVIDUALLY WRAPPED BD SAFETYGLIDE IN INDIVIDUAL BLISTERPACK WAS NOTED, STATING THE PRODUCT TO BE CAT# 305932. BASED ON THE PHOTOS PROVIDED, BD CAN CONFIRM THE CUSTOMER'S REPORTED DEFECT (MISLABELING) OF THE CARTON FOR THIS CUSTOMER COMPLAINT. CAPA(B)(4) WERE INITIATED BY THE HOLDREGE PLANT TO ADDRESS THIS LOT AND EVENT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OUTSIDE PACKAGING OF 1 ML BD SYRINGE WITH SAFETYGLIDE¿ WITH NEEDLES WERE LABELED INCORRECTLY. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. BATCH 8002686 DOES NOT EXIST FOR MATERIAL 305930. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN.  DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUTSIDE PACKAGING OF 1 ML BD SYRINGE WITH SAFETYGLIDE¿ WITH NEEDLES WERE LABELED INCORRECTLY. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422925 BD SYRINGE WITH SAFETYGLIDE¿ WITH NEEDLE SYRINGE WITH NEEDLE MEG BD MEDICAL - DIABETES CARE 8002686 30382903059035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other