BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ SYRINGE ALLERGIST TRAY WITH NEEDLE

    MDR report key: 7526774 · Received May 18, 2018

    Report

    Report Number
    1920898-2018-00317
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Date of Event
    April 25, 2018
    Report Date
    June 12, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    UDI-DI
    30382903059509
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO INVESTIGATIONS WERE CARRIED OUT. FIRST INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 1ML, 13MM, 27G BD SAFETYGLIDE ALLERGY SYRINGE WITH THE TRAY COVER FROM LOT # 7072717. CUSTOMER STATES THAT AFTER INJECTION WHEN ATTEMPTING TO ACTIVATE THE SAFETY MECHANISM, THE ENTIRE NEEDLE FIXTURE FLEW OFF OF THE SYRINGE AND FLEW ACROSS THE ROOM. THE SYRINGE WAS RETURNED WITH THE HUB-NEEDLE-SAFETY MECHANISM ASSEMBLY SEPARATED FROM THE BARREL. NO DAMAGE TO THE BARREL WAS OBSERVED. SAMPLE WILL BE FORWARDED TO MANUFACTURING (B)(4) ON 11MAY2018 FOR FURTHER REVIEW. SECOND INVESTIGATION SUMMARY: ON 22MAY2018, (B)(4( RECEIVED ONE (1) 1ML, 13MM, 27G BD SAFETYGLIDE ALLERGY SYRINGE WITH TYVEK TRAY COVER FROM BATCH# 7072717. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. DAMAGE TO THE HUB CORE AND BARREL TIP WERE NOTED, CONSISTENT WITH A MISALIGNMENT DURING PRODUCTION, SPECIFICALLY WITH THE ASSEMBLY OF THE HUB TO THE BARREL. WHEN THIS OCCURS, AN INCOMPLETE SEATING OF THE HUB WITHIN THE BARREL TIP CAN OCCUR AND LEAD TO THE HUB DETACHING FROM THE REMAINDER OF THE DEVICE, WITH THE CANNULA/SAFETY MECHANISM, EITHER DURING TRANSPORT OR INITIAL ACTIVATION OF THE PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7072717. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. SYRINGE ASSEMBLY ¿ THERE WERE FIVE (5) BATCHES OF MATERIAL# 8365025(SYRINGE 1.0ML ASM 27GA 1/2IN SG SM700169) THAT WENT INTO THE FINISHED BATCH# 7072717: BATCH # 7051583 WAS MANUFACTURED FROM 09APR2017 TO 20APR2017. BATCH # 7051582 WAS MANUFACTURED FROM 09APR2017 TO 17APR2017. BATCH # 7040804 WAS MANUFACTURED FROM 30MAR2017 TO 07APR2017. BATCH # 7040803 WAS MANUFACTURED FROM 29MAR2017 TO 07APR2017. BATCH # 7040800 WAS MANUFACTURED FROM 10MAR2017 TO 17MAR2017. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF SAFETY MECHANISM BROKE (SAFETYGLIDE) WITH LOT #7072717 REGARDING ITEM #305950. 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN ATTEMPTING TO ACTIVATE THE SAFETY FEATURE ON A BD SAFETYGLIDE¿ SYRINGE ALLERGIST TRAY WITH NEEDLE, THE ¿ENTIRE NEEDLE FIXTURE FLEW OFF OF THE SYRINGE AND FLEW ACROSS THE ROOM¿. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370056 BD SAFETYGLIDE¿ SYRINGE ALLERGIST TRAY WITH NEEDLE SAFETY SYRINGE WITH NEEDLE MEG BD MEDICAL - DIABETES CARE 7072717 30382903059509

    Patients

    Seq Age Sex Outcome Treatment
    1 Other