BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3/10 ML BD SAFETYGLIDE INSULIN SYRINGE WITH 31G X 5/19 IN ATTACHED NEEDLE

    MDR report key: 10732299 · Received October 26, 2020

    Report

    Report Number
    1920898-2020-01472
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    September 29, 2020
    Report Date
    November 12, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    PMA / PMN Number
    K992734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-10-23. INVESTIGATION SUMMARY: CUSTOMER RETURNED (6) 3/10CC, 8MM, 31G BD SAFETYGLIDE INSULIN SYRINGES IN OPEN BLISTER PACKS FROM LOT # 9143740. CUSTOMER STATES THAT THERE IS LIQUID THAT IS ALREADY PRESENT IN THE NEEDLES THAT HE HAS FOUND IN TWO NEEDLES. ALL RETURNED SYRINGES WERE EXAMINED AND NO FOREIGN MATTER WAS OBSERVED. HOWEVER, WHEN FULLY DEPRESSING THE PLUNGER ROD, A SMALL, CLEAR DROPLET OF MATERIAL CAME OUT OF THE CANNULA ON 3 OUT OF 6 SAMPLES. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY POLYPROPYLENE. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT ON LOT # 9143740. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 0.3ML, SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. ROOT CAUSE: ZM NOTIFICATION 200824931 WAS CREATED FOR EXCESSIVE SILICONE. THE ROOT CAUSE SILICONE GUN #3 WAS OUT OF ALIGNMENT. CORRECTION: THE SILICONE GUN #3 WAS ADJUSTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 3/10 ML BD SAFETYGLIDE¿ INSULIN SYRINGES WITH 31G X 5/19 IN ATTACHED NEEDLES EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305937, BATCH NO: 9143740. COMPLAINT 2 OF 2. MY HUSBAND'S LATEST PRESCRIPTION OF SYRINGES HAS LIQUID THAT IS ALREADY PRESENT IN THE NEEDLES THAT HE HAS FOUND IN TWO NEEDLES. THERE MAY BE MORE CASES BUT THIS WEEK HE NOTICED THE SYRINGE HE WAS PREPARING ALREADY HAD LIQUID HE WAS ABLE TO EXPEL. HUSBAND WAS PREPARING A SYRINGE TO PULL IN INSULIN HE PULLED AIR IN AND UPON SAW CLEAR LIQUID DROPLETS EJECT FROM THE NEEDLE. WIPED DROPLETS ON SYRINGE WRAPPER AND DID NOT USE THIS. THIS OCCURRED AGAIN ON (B)(6) 2020. LOT # 9143740, CAT # 305937, DATE OF EVENT: (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 3/10 ML BD SAFETYGLIDE¿ INSULIN SYRINGES WITH 31G X 5/19 IN ATTACHED NEEDLES EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305937 BATCH NO: 9143740. COMPLAINT 2 OF 2. MY HUSBAND'S LATEST PRESCRIPTION OF SYRINGES HAS LIQUID THAT IS ALREADY PRESENT IN THE NEEDLES THAT HE HAS FOUND IN TWO NEEDLES. THERE MAY BE MORE CASES BUT THIS WEEK HE NOTICED THE SYRINGE HE WAS PREPARING ALREADY HAD LIQUID HE WAS ABLE TO EXPEL. HUSBAND WAS PREPARING A SYRINGE TO PULL IN INSULIN HE PULLED AIR IN AND UPON SAW CLEAR LIQUID DROPLETS EJECT FROM THE NEEDLE. WIPED DROPLETS ON SYRINGE WRAPPER AND DID NOT USE THIS. THIS OCCURRED AGAIN ON (B)(6) 2020. LOT # 9143740. CAT # 305937. DATE OF EVENT: (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203283 3/10 ML BD SAFETYGLIDE INSULIN SYRINGE WITH 31G X 5/19 IN ATTACHED NEEDLE SYRINGE, ANTISTICK MEG BD MEDICAL - DIABETES CARE 9143740

    Patients

    Seq Age Sex Outcome Treatment
    1