BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 18784136 · Received February 26, 2024

    Report

    Report Number
    9610847-2024-00042
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    January 29, 2024
    Report Date
    April 29, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903097020
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE 2 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF SCALE MARKING ISSUE WAS CONFIRMED UPON INSPECTION OF THE SAMPLE PHOTOS. ANALYSIS OF THE SAMPLE PHOTOS SHOWED THAT ONE OF THE SYRINGES WAS MISSING THE ¿L¿ IN THE ¿ML¿ MARKING AND THE SECOND WAS MISSING HALF OF THE ¿L¿ MARKING. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS ASSOCIATED TO OUR MARKING PROCESS. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. 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. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 309702 AND LOT NUMBER 3212548. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK HAD SCALE MARKING ISSUES IT WAS REPORTED BY THE CUSTOMER REPORTED WHEN USING BD 3ML SYRINGE IN OUR FILLING OPERATIONS, WE ARE SEEING HUNDREDS OF SYRINGES THAT ARE BEING REJECTED DUE TO THE PRINTED ¿L¿ IN ¿ML¿ BEING PARTIALLY MISSING AND COMPLETELY MISSING. WE ALSO OPENED THE LETTERING ON THE SYRINGE BARREL IS MISSING THE "L" IN ML). VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PO #: (B)(4). DEFECT MATERIAL DESCRIPTION: SYRINGE TRAY, 3ML BD 25PK (REF. (B)(4)). LOT NUMBER: 3212548. ITEM CODE: 309702. DEFECTIVE QUANTITY: 454. DEFECT DESCRIPTION: WHEN USING BD 3ML SYRINGE LOT 3212548 IN OUR FILLING OPERATIONS, WE ARE SEEING HUNDREDS OF SYRINGES THAT ARE BEING REJECTED DUE TO THE PRINTED ¿L¿ IN ¿ML¿ BEING PARTIALLY MISSING AND COMPLETELY MISSING. WE ALSO OPENED DMR-0197 BACK ON 27OCT2023 BD 3 ML SAME SYRINGE LOT # 3212548 THE LETTERING ON THE SYRINGE BARREL IS MISSING THE "L" IN ML) WE RECEIVED 81,000 OF THIS BD LOT. OBSERVED DATE: JANUARY 9, 2024. OBSERVED DURING WHICH PROCESS STAGE: COMPOUNDING. IR NUMBER IF LAUNCHED: N/A. SAMPLE AVAILABILITY FOR SUPPLIER TO INVESTIGATE: YES. IS DEFECTIVE EVIDENCE (I.E. PICTURES; TEST RESULTS ETC.) AVAILABLE? YES. IS PATIENT IMPACTED? NO. IF DEFECT HAS BEEN REPORTED TO THIRD PARTY? NO. IF THE DEFECT REPORT FROM QUVA CUSTOMER? NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657697 BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3212548 30382903097020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown