BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 19106326 · Received April 15, 2024

    Report

    Report Number
    1911916-2024-00258
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    March 19, 2024
    Report Date
    April 24, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305180 AND LOT NUMBER 3236136. 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.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL #:305180 BATCH#:3236136 IT WAS REPORTED BY CUSTOMER THAT WHEN THE INSULIN WAS TAKEN, A CORE FROM THE VIAL WAS FOUND AT THE BOTTOM OF IT. EVENTS LIKE THIS HAVE ALREADY HAPPENED WITH A HEPARIN VIAL AS WELL. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CHC COMPLAINT REFERENCE #: (B)(4) HOSPITAL COMPLAINT REFERENCE #: (B)(4) CUSTOMER (HOSPITAL) NAME: INST.UNIV.CARDIOLOGIE DE PNEUMOLOGIE QUE CUSTOMER ADDRESS: (B)(6) CONTACT NAME: (B)(6) PHONE: (B)(6) E-MAIL: (B)(6) CORRESPONDENCE LANGUAGE: FRENCH CAT# OF PRODUCT BEING COMPLAINED: BD305180 DESCRIPTION OF PRODUCT: NEEDLE 18GX1.5IN BLUNT FILL ST SP=PK 100EA/PK 10PK/CA. LOT OR S/N: 3236136 COMPLAINT CATEGORY: OTHER - FILL IN COMPLAINTS EXPLANATION REPORTABLE: NO INCIDENT DATE: (B)(6) 2024 HOSPITAL COMPLAINT REFERENCE #: (B)(4) DETAILS OF COMPLAINT (REPORTED ISSUE): NOUS SOUHAITONS VOUS FAIRE PART D'UNE SITUATION PROBLÉMATIQUE SURVENUE. VOUS TROUVEREZ TOUTES LES INFORMATIONS DANS LE FORMULAIRE EN PJ. DANS L'ATTENTE DE VOTRE RÉPONSE POUR LES INSTRUCTIONS DE RETOUR DU PRODUIT DÉFECTUEUX, JE VOUS SOUHAITE UNE BELLE JOURNÉE. LORSQUE DU PRÉLÈVEMENT DE L'INSULINE, UNE CAROTTE DU VIAL S'EST RETROUVÉ DANS LE FOND DE CELUI-CI. DES ÉVÈNEMENTS COMME CELA S'EST DÉJÀ PRODUIT AVEC UN VIAL D'HÉPARINE ÉGALEMENT. TRANSLATION: WE WOULD LIKE TO INFORM YOU OF A PROBLEMATIC SITUATION THAT HAS ARISEN. YOU WILL FIND ALL THE INFORMATION IN THE FORM ON PJ. WAITING FOR YOUR RESPONSE FOR THE INSTRUCTIONS FOR RETURNING THE DEFECTIVE PRODUCT. PER COMPLAINT DETAILS: WHEN THE INSULIN WAS TAKEN, A CORE FROM THE VIAL WAS FOUND AT THE BOTTOM OF IT. EVENTS LIKE THIS HAVE ALREADY HAPPENED WITH A HEPARIN VIAL AS WELL. HAS A PATIENT SUFFERED FROM THIS PROBLEM? (AH-223) YES NO AH-223: 2324-0584289 COMPLAINT QUANTITY NOT PROVIDED. **FRENCH CUSTOMER INDICATED THAT THEY WISH TO BE PROVIDED WITH THE FINAL RESULTS OF THIS INVESTIGATION. PLEASE COPY [email protected] WHEN SENDING TO THE CUSTOMER.** COMPLAINT NOTICED: DURING / AFTER USE PROBLEM FREQUENCY: A FEW TIMES CUSTOMER EXPOSURE: PATIENT INJURY: YES HAS HEALTH CANADA BEEN INFORMED? UNKNOWN QTY AFFECTED: 1 EA SAMPLES AVAILABLE? NO IS CUSTOMER REQUESTING AN RGA?: NO RETURN QTY: ADDITIONAL INFORMATION: VEUILLEZ CONFIRMER SI VOUS AVEZ BEL ET BIEN UN ÉCHANTILLON PHYSIQUE DU PRODUIT EN VOTRE POSSESSION POUR FINS D¿ENQUÊTE, CAR VOUS AVIEZ RÉPONDU « NON » À CETTE QUESTION SUR LE FORMULAIRE DE RAPPORT D¿INCIDENT, MAIS AVIEZ ÉGALEMENT MENTIONNÉ : « EN ATTENTE DE VOTRE RÉPONSE SUR LA FAÇON DE RETOURNER LE PRODUIT DÉFECTUEUX ». NOUS N'AVONS PAS D'ÉCHANTILLON. - WE DON¿T HAVE A SAMPLE. · LE RAPPORT INDIQUE QUE LE PATIENT A SUBI UN PRÉJUDICE GRAVE. LE PROBLÈME EST-IL SURVENU PENDANT QUE LE DISPOSITIF ÉTAIT UTILISÉ CHEZ UN PATIENT ? VEUILLEZ DÉCRIRE TOUT PRÉJUDICE SUBI PAR LE PATIENT, TOUTE COMPLICATION OU TOUTE CONSÉQUENCE NÉGATIVE ATTRIBUABLE À L¿INCIDENT. UN AH 223 A ÉTÉ COMPLÉTÉ, MAIS AUCUN CONTACT AVEC UN PATIENT EN TANT QUE TEL. AN AH 223 WAS COMPLETED, BUT NO CONTACT WITH A PATIENT AS SUCH.

    Description of Event or Problem · 0

    MATERIAL#: 305180, BATCH#: 3236136. IT WAS REPORTED BY CUSTOMER THAT WHEN THE INSULIN WAS TAKEN, A CORE FROM THE VIAL WAS FOUND AT THE BOTTOM OF IT. EVENTS LIKE THIS HAVE ALREADY HAPPENED WITH A HEPARIN VIAL AS WELL. COMPLAINT NOTICED: DURING / AFTER USE, PROBLEM FREQUENCY: A FEW TIMES, CUSTOMER EXPOSURE: PATIENT INJURY: YES, HAS HEALTH CANADA BEEN INFORMED? UNKNOWN, QTY AFFECTED: 1 EA, SAMPLES AVAILABLE? NO, IS CUSTOMER REQUESTING AN RGA?: NO, RETURN QTY. ADDITIONAL INFORMATION RECEIVED 11APR2024: FOLLOW UP INFORMATION PROVIDED REGARDING PATIENT OUTCOME: AN AH 223 WAS COMPLETED, BUT NO CONTACT WITH A PATIENT AS SUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832615 NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 3236136 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown