BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 8700614 · Received June 14, 2019

    Report

    Report Number
    2243072-2019-01186
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 14, 2019
    Report Date
    May 31, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    SEE H.10
    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

    DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). PMA/510(K)#: THERE ARE TWO POTENTIAL PMA/510(K)#S ASSOCIATED WITH THIS DEVICE. BECAUSE THE LOT # AND MANUFACTURER OF THE DEVICE ARE UNSPECIFIED, IT IS NOT CLEAR WHICH APPLIES TO THE DEVICE FROM THIS COMPLAINT. THE POTENTIAL PMA/510(K)#S ARE K980987 IF THE DEVICE WAS MANUFACTURED IN (B)(4), AND K151766 IF THE DEVICE WAS MANUFACTURED IN (B)(4). DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS LOT NUMBER WAS UNKNOWN. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED RATIONALE: NO CAPA IS REQUIRED. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE SYRINGE 3ML LL 200 S/C EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309657 BATCH NO. UNKNOWN (PROVIDED M193356). DESCRIPTION OF ISSUE: CUSTOMER REPORTED PARTICLES IN THE SYRINGE AFTER FILLING WITH INSULIN DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 3. NUMBER OF OCCURRENCES: 3. ITEM NUMBER: 3 ML SYRINGE ¿ 309657. PRODUCT LOT NUMBER: M193356 BOX. FOR BD PRODUCT ONLY, ARE SAMPLES AVAILABLE FOR INVESTIGATION? YES. DOES CUSTOMER AUTHORIZE BD TO CONTACT CUSTOMER TO OBTAIN SAMPLE(S)? YES. DID ISSUE CAUSE ANY INJURY? IF YES, WHAT TYPE OF INJURY? NO INJURY. MEDICAL INTERVENTION NEEDED? IF YES, WHO WAS THE 3RD PARTY AND WHAT WAS THE ASSISTANCE/TREATMENT? NO. RESOLUTION: EXPLAINED THAT BD MIGHT FOLLOW UP WITH CUSTOMER REGARDING RETURNING SYRINGE/NEEDLE. NO FURTHER TANDEM FOLLOW UP IS REQUIRED. NOTE: PRODUCT CATEGORY = NEEDLE/SYRINGE ISSUE". ADDITIONAL INFORMATION FROM CUSTOMER: CUSTOMER STATED THAT THE PARTICLES IN THE SYRINGE LOOKED LIKE SMALL PLASTIC PIECES. IT SEEMED LIKE PLASTIC FROM MANUFACTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493463 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other