BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML ST BULK CONVENIENCE PAK

    MDR report key: 18698250 · Received February 13, 2024

    Report

    Report Number
    9610847-2024-00028
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    January 17, 2024
    Report Date
    April 23, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903097013
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 309701 AND LOT NUMBER 3212533. 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.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1ML ST BULK CONVENIENCE PAK STOPPER WAS DEFECTIVE/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: "I'M WRITING TO LET YOU KNOW ABOUT A PROBLEM I'VE HAD THIS PAST MONTH WITH THE SYRINGES IN THE TIP1CC SLIP BULKS. THE LIQUID PASSES BY THE BLACK RUBBER AND FLOWS DOWN THE PISTON. SO, CONTAMINATED PRODUCT. SEVERAL SYRINGES WITH THE PLASTIC STRIPED." JE VOUS ÉCRIS POUR VOUS FAIRE PART D'UN PROBLÈME RENCONTRÉ CE DERNIER MOIS AVEC LES SERINGUES DES BULKS DE SLIP TIP 1CC. LE LIQUIDE PASSE À CÔTÉ DU CAHOUTCHOU NOIR ET COULE AU NIVEAU DU PISTON. DONC, PRODUIT CONTAMINÉ. PLUSIEURS SERINGUES AVEC LE PLASTIQUE RAYÉ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809350 BD SYRINGE 1ML ST BULK CONVENIENCE PAK PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3212533 30382903097013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown