BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 26X3/8 IB

    MDR report key: 8777183 · Received July 10, 2019

    Report

    Report Number
    1911916-2019-00681
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    May 17, 2019
    Report Date
    July 10, 2019
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMI
    UDI-DI
    30382903051107
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. WHILE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, FOREIGN MATERIAL (FM) CAN BE INTRODUCED TO THE FLUID PATH DURING THE MANUFACTURING PROCESS WHICH COULD CAUSE THE NEEDLE TO BECOME CLOGGED. ALL PRODUCT IS AUTOMATICALLY CHECKED FOR CLOGGED NEEDLES DURING THE PRODUCTION PROCESS. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE CLOGGED / BLOCKED FOR LOT #8172842 ITEM #305110. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. ROOT CAUSE DESCRIPTION: FOREIGN MATERIAL (FM) CAN BE INTRODUCED TO THE FLUID PATH DURING THE MANUFACTURING PROCESS WHICH COULD CAUSE THE NEEDLE TO BECOME CLOGGED. ALL PRODUCT IS AUTOMATICALLY CHECKED FOR CLOGGED NEEDLES DURING THE PRODUCTION PROCESS. RATIONALE: BASED ON THE INVESTIGATION CONCLUSION AND WITHOUT A SAMPLE TO ANALYZE, THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED NOR COULD THIS SYMPTOM BE CORRELATED WITH A POTENTIAL CAUSE LINKED TO THE BD PROCESS. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE NEEDLE 26X3/8 IB HAS BEEN FOUND CLOGGED BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305110, BATCH NO: 8172842. IT WAS REPORTED THAT ON 05/17 THE NEEDLE WAS CLOGGED AND WOULD NOT ALLOW FOR THE INSULIN AND AIR TO BE PUSHED OUT. EVENT DESCRIPTION PER EMAIL STATES: "DESCRIPTION OF ISSUE: CUSTOMER REPORTED HAVING ISSUES WITH 2 NEEDLES GIVING PROBLEMS BEFORE ATTEMPTING FILLING THE CARTRIDGE WITH BEING DIFFICULT PUSHING THE INSULIN AND AIR OUT. CUSTOMER IS NOW LOW ON SUPPLIES AND REQUESTED REPLACEMENTS. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 3. NUMBER OF OCCURRENCES: 2 WITHIN LAST MONTH, MOST RECENT OCCURRED LAST NIGHT. ITEM NUMBER: 3 ML SYRINGE ¿ 309657. 26 G, 3/8¿ NEEDLE ¿ 305110. PRODUCT LOT NUMBER: FROM LAST NIGHT- 8172842. FOR BD PRODUCT ONLY, ARE SAMPLES AVAILABLE FOR INVESTIGATION? YES. DOES CUSTOMER AUTHORIZE BD TO CONTACT CUSTOMER TO OBTAIN SAMPLE(S)? NO. DID ISSUE CAUSE ANY INJURY? IF YES, WHAT TYPE OF INJURY? NO. MEDICAL INTERVENTION NEEDED? IF YES, WHO WAS THE 3RD PARTY AND WHAT WAS THE ASSISTANCE/TREATMENT? NO. RESOLUTION: CUSTOMER DECLINED BD FOLLOW UP FOR RETURNING PRODUCT. NO FURTHER TANDEM FOLLOW UP IS REQUIRED. NOTE: PRODUCT CATEGORY = NEEDLE/SYRINGE ISSUE." NEEDLE BLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572282 NEEDLE 26X3/8 IB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND COMPANY 8172842 30382903051107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other