BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 8802642 · Received July 18, 2019

    Report

    Report Number
    1920898-2019-00682
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    July 3, 2019
    Report Date
    August 30, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (1) 1/2CC, 8MM, 31G SYRINGE IN AN OPEN POLY BAG WITH THE SHELF CARTON FROM LOT # 9042865. CUSTOMER STATES THAT THERE WAS NO PERFORATION AND A DAMAGED SHIELD. THE RETURNED SAMPLE WAS EXAMINED AND EXHIBITED NO PERFORATIONS ON THE POLY BAG, A CRUSHED PLUNGE CAP, AND A BROKEN THUMB PRESS ON THE PLUNGER ROD. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9042865. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.PROCESS SUMMARY: A DIAL TRANSFERS THE CORRECT NUMBER OF SYRINGES TO A TUBE WHERE THEY DROP BY GRAVITY THROUGH THE TUBE COMING TO REST ON TOP OF THE POLYBAG SEALING JAWS. THE POLYBAG IS FORMED BY WEB THAT IS WRAPPED AROUND A METAL TUBE WHERE THE SIDES OF THE WEB OVERLAP AND ARE SEALED TO FORM THE VERTICAL SEAL. SEALING JAWS FORM THE POLYBAG BOTTOM, AS WELL AS THE TOP OF THE PREVIOUS POLYBAG. BETWEEN THE SEALING JAWS IS A KNIFE THAT FORMS THE PERFORATION AND A KNIFE THAT SEVERS THE BAG FROM THE ROLL.WHEN THE SYRINGES DROPPED THROUGH THE TUBE INTO THE POLYBAG, ONE SYRINGE MOST LIKELY CAUGHT ON ONE OF THE OTHER SYRINGES IN THE BAG AND DID NOT DROP TO THE BOTTOM OF THE BAG, LEAVING THE TOP OF THE SYRINGE IN THE TOP SEAL AND PERFORATION AREA OF THE POLYBAG. WITH THE SYRINGE IN THIS POSITION, THE KNIFE WOULD NOT HAVE BEEN ABLE TO FORM THE PERFORATION AND THE JAW WOULD NOT HAVE BEEN ABLE TO COMPLETELY SEAL THE BAG. THE CAP AND PLUNGER THUMB PRESS WOULD HAVE BEEN DAMAGED BY THE JAW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS NO PERFORATION ON THE PACKAGING WHILE OPENING UP THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE DURING USE, SO IT HAD TO BE "RIPPED" OPEN, AND THE SYRINGE SHIELD WAS FOUND "CRUSHED" INSIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPOUSE STATED THERE WAS NO PERFORATION MAKING IT EASIER TO OPEN BAG SO SHE HAD TO RIP IT OPEN. STATED, 1 SYRINGE HAD A DAMAGED SHIELD. IT WAS CRUSHED."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 THERE WAS NO PERFORATION ON THE PACKAGING WHILE OPENING UP THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE DURING USE, SO IT HAD TO BE "RIPPED" OPEN, AND THE SYRINGE SHIELD WAS FOUND "CRUSHED" INSIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPOUSE STATED THERE WAS NO PERFORATION MAKING IT EASIER TO OPEN BAG SO SHE HAD TO RIP IT OPEN. STATED, 1 SYRINGE HAD A DAMAGED SHIELD. IT WAS CRUSHED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599317 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9042865 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1 Other