BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG

    MDR report key: 10059660 · Received May 14, 2020

    Report

    Report Number
    1920898-2020-00520
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Date of Event
    April 24, 2020
    Report Date
    April 27, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. INVESTIGATION SUMMARY: LEVEL B INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 7TH RELATED COMPLAINT FOR NEEDLE HUB SEPARATES ON LOT # 9252570. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A 3/10CC, 6MM, 31G SYRINGE WITH AN OPEN POLY BAG FROM LOT # 9252570. CUSTOMER STATES THAT THE NEEDLE HUB SEPARATES INTO SHIELD. THE PROVIDED PHOTOS WERE EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. MANUFACTURING ((B)(4)) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9252570. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200845676, 200845565] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE TWO (2) NOTIFICATIONS [200845567, 200845495] NOTED FOR HIGH SHIELD PULL. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES AND/OR 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. ROOT CAUSE DESCRIPTION: AS PER INVESTIGATION COMPLETED BY MANUFACTURING UNDER INVESTIGATION CHILD, ON 07 MAY 2020, (B)(4) RECEIVED PHOTO COMPLAINT. A VISUAL EVALUATION OF PHOTO FOUND (1) SYRINGE WITH NO NEEDLE ASSEMBLIES ATTACHED. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE TIP OF THE BARRELS, OR ANYWHERE ON THE SYRINGE. THERE DID NOT APPEAR TO BE ANY CORE PIN DAMAGE. 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. DHR, L2L DISPATCHES, AND LOGBOOK ENTRIES WERE LOOKED AT, NOTHING PERTAINING TO THIS DEFECT WAS FOUND. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. TIP-2019-37 WAS IMPLEMENTED ON (B)(6) 2019 FOR INCREASED SAMPLING FOR NEEDLE HUB SEPARATES IN 0.3ML. CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 0.3ML 31GA 6MM WHOLEUNIT 10BAG EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 324909 BATCH NO. 9252570. FROM PHONE CALL, CALLED CONSUMER BACK TO OBTAIN ADDITIONAL PRODUCT COMPLAINT INFORMATION IN ORDER TO COMPLETE FILE. CONSUMER STATED "I HAVE ONE MINUTE TO TALK TO YOU BEFORE I HAVE A MEETING". CONSUMER CONFIRMED HE HAS SAMPLES TO SEND BACK AND DATE OF EVENT IS UNKNOWN. ADVISED CONSUMER THAT HE WILL BE RECEIVING A MAIL KIT AND PRODUCT REPLACEMENT VOUCHER. EMAIL RECEIVED: REASON FOR CALL: AS I SUBMITTED IN MY ORIGINAL EMAIL, THE ENTIRE TOP OF THE SYRINGE CAME APART WHEN TRYING TO REMOVE THE ORANGE CAP. THE SYRINGE IS UNUSABLE. THIS IS NOT THE FIRST TIME THIS HAS HAPPENED WITH BD VEO ULTRA-FINE SYRINGES BUT THE FIRST TIME I AM SUBMITTING A COMPLAINT AS I CANNOT CONTINUE TO HAVE SYRINGES WASTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518519 SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG SYRINGE FMF BD MEDICAL - DIABETES CARE 324909 9252570 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other