BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 10715224 · Received October 21, 2020

    Report

    Report Number
    1213809-2020-00732
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    September 28, 2020
    Report Date
    October 8, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903059035
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE. MEDICAL DEVICE TYPE: FMI. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K980580 (SYRINGE), PMA / 510(K)#: K951254 (NEEDLE). (B)(4). INVESTIGATION SUMMARY: TWO PHOTOS AND ONE OPENED 1ML SAFETYGLIDE COMBO PACKAGE WERE RECEIVED, CONFIRMED TO BE FROM BATCH #0140992 BY OUR QUALITY TEAM. THE SAMPLE WAS VISUALLY EVALUATED. THE PACKAGE CONTAINED A SHIELDED SG NEEDLE AND A 1ML S/T SYRINGE. THE SYRINGE WAS OBSERVED TO HAVE MULTIPLE BROWN FOREIGN MATTER PARTICLES EMBEDDED IN THE BARREL, WITH MAJORITY AROUND THE TIP, BUT SOME ALSO FOUND IN THE WALL. MANY PARTICLES WERE LARGER THAN LEVEL 3 IN SIZE, WHICH IS REJECTABLE PER PRODUCT SPECIFICATION. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE INVESTIGATION, THE POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE EMBEDDED FM IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START UP. PER PROCEDURE, AFTER START UP, ALL MOLDED PARTS ARE SCRAPPED UNTIL NO DEGRADED PLASTIC IS OBSERVED. IF THIS IS NOT PERFORMED THOROUGHLY A PIECE WITH THIS CONDITION CAN GET THROUGH. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE WITH THE SAMPLE AND PHOTOS PROVIDED. ROOT CAUSE DESCRIPTION: POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. RATIONALE: THE AQL FOR EMBEDDED FOREIGN MATTER IS 0.65%. THE DEFECTIVE RATE IDENTIFIED IS (B)(4). NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 0140992 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BROWN FOREIGN MATTER WAS FOUND IN THE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE PACKAGING BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE A WEIRD SITUATION WITH A SYRINGE. ONE OF THE TECHS OPENED AN 1ML SYRINGE/SAFETY NEEDLE PACKAGE AND THE SYRINGE IS CONTAMINATED WITH A BROWN SUBSTANCE IN IT. THE TECH SAID THE PACKAGE WAS CLOSED AND NOTICED THE DIRTY SYRINGE WHILE OPENING IT FOR A STERILE TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180444 BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 305903 0140992 30382903059035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other