BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL S/C 200

    MDR report key: 18481018 · Received January 9, 2024

    Report

    Report Number
    1213809-2024-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    December 18, 2023
    Report Date
    June 5, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO OF A 10ML LUER-LOK SYRINGE WAS RECEIVED AND EVALUATED. THE IMAGE SHOWS A SEALED PACKAGE WITH THE SYRINGE INSIDE WITH FOUR BROWNISH STAINS ON THE BARREL CONSISTENT WITH EMBEDDED FOREIGN MATTER. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE EMBEDDED FM IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START UP. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3130674 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    MATERIAL#: 302995 BATCH#: 3130674. IT WAS REPORTED BY CUSTOMER THAT I AM CONTACTING YOU REGARDING AN ISSUE NOTED DURING PROCESS OPERATIONS HERE AT LYELL IMMUNOPHARMA, BOTHELL WA (LYFE), RELATED TO THE USE OF BD MEDICAL ITEM 302995, 10 ML BD LUER-LOK¿ SYRINGE; SPECIFICALLY, BROWN SPECS FOUND WITHIN THE PLASTIC PACKAGING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I AM CONTACTING YOU REGARDING AN ISSUE NOTED DURING PROCESS OPERATIONS HERE AT LYELL IMMUNOPHARMA, BOTHELL WA (LYFE), RELATED TO THE USE OF BD MEDICAL ITEM 302995, 10 ML BD LUER-LOK¿ SYRINGE; SPECIFICALLY, BROWN SPECS FOUND WITHIN THE PLASTIC PACKAGING. PRELIMINARY EXAMINATION INDICATES NO ASSIGNABLE CAUSES FOUND IN RELATION TO OPERATIONS, EQUIPMENT, OR PROCESSING DURING MANUFACTURING ACTIVITIES AT LYELL. THE ANOMALY IN QUESTION WAS NOTED UPON VISUAL INSPECTION OF THE ITEM PRIOR TO OPENING AND USE IN OPERATIONS (PLEASE SEE PHOTO BELOW). AS A RESULT OF THIS EVENT, I RESPECTFULLY REQUEST YOUR ASSISTANCE IN FILING A COMPLAINT WITH THE QA DEPARTMENT AT BD, AT YOUR EARLIEST CONVENIENCE. PLEASE PROVIDE US WITH THE FOLLOWING: COMPLAINT NUMBER THAT WE MAY DOCUMENT FOR REFERENCE. FORMAL RESPONSE LETTER, PROVIDING OUTCOME OF INVESTIGATION, CAUSE(S), AND CORRECTIVE ACTION(S) (WITHIN 30 DAYS OF THIS EMAIL (DECEMBER 16TH, 2023). LYELL DESCRIPTION: 10 ML BD LUER-LOK¿ SYRINGE ITEM: 1000061. CORNING SUPPLIER PART: 302995 SUPPLIER LOT: 3130674.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL S/C 200 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I AM CONTACTING YOU REGARDING AN ISSUE NOTED DURING PROCESS OPERATIONS HERE AT LYELL IMMUNOPHARMA, BOTHELL WA (LYFE), RELATED TO THE USE OF BD MEDICAL ITEM 302995, 10 ML BD LUER-LOK¿ SYRINGE; SPECIFICALLY, BROWN SPECS FOUND WITHIN THE PLASTIC PACKAGING. PRELIMINARY EXAMINATION INDICATES NO ASSIGNABLE CAUSES FOUND IN RELATION TO OPERATIONS, EQUIPMENT, OR PROCESSING DURING MANUFACTURING ACTIVITIES AT LYELL. THE ANOMALY IN QUESTION WAS NOTED UPON VISUAL INSPECTION OF THE ITEM PRIOR TO OPENING AND USE IN OPERATIONS (PLEASE SEE PHOTO BELOW). AS A RESULT OF THIS EVENT, I RESPECTFULLY REQUEST YOUR ASSISTANCE IN FILING A COMPLAINT WITH THE QA DEPARTMENT AT BD, AT YOUR EARLIEST CONVENIENCE." LYELL DESCRIPTION: 10 ML BD LUER-LOK¿ SYRINGE ITEM: 1000061 BATCH: CORNING SUPPLIER PART: 302995 SUPPLIER LOT: 3130674

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598479 BD SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3130674 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown