BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL BNS

    MDR report key: 11276050 · Received February 3, 2021

    Report

    Report Number
    1213809-2021-00058
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    January 11, 2021
    Report Date
    February 17, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-02-08. H6: INVESTIGATION SUMMARY. TWO PHOTOS AND 8 LOOSE 10ML SYRINGES WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. ALL SYRINGES HAD MISSING PRINT IN THE UPPER HALF OF THE BARRELS¿ MARKINGS BETWEEN 6ML AND 10ML. THE PRINT WAS OBSERVED TO HAVE BEEN SCRATCHED OFF AS EVIDENCED BY THE SCUFF MARKS IN THE MISSING PRINT AREAS OF ALL THE SAMPLES. ACCEPTANCE/REJECTION WAS DETERMINED BY PRINT MISSING MORE THAN 50% OF ANY ONE ITEM, SUCH AS A GRAD LINE, PER PRODUCT SPECIFICATION. 2 OF THE SAMPLES HAD ACCEPTABLE PRINT QUALITY PER PRODUCT SPECIFICATION, WHILE 6 SAMPLES HAD REJECTABLE PRINT QUALITY. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 0127987 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 10ML LL BNS HAD SCALE MARKING PERMANENCY ISSUES BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "PLEASE FIND ATTACHED FORM RFV21.004 FOLLOWING TWO NON-CONFORMITIES DETECTED IN PRODUCTION (SYRINGE GRADUATIONS ERASED) ON : BD SERINGULE 10ML LUER LOCK BULK LUER LOCK. YOUR REFERENCE : 301029. OUR REFERENCE : 76210104. YOUR LOT : 0127987. OUR LOT: 518575. PLEASE INFORM US OF THE CAUSES OF THIS NON-COMPLIANCE AS WELL AS THE CORRECTIVE AND PREVENTIVE ACTIONS TAKEN TO AVOID ANY RECURRENCE. CLÉMENT METTRAY WILL GET BACK TO YOU CONCERNING THE METHODS OF TAKING BACK THE DEFECTIVE GOODS. QUANTITY RECEIVED/ QUANTITÉ REÇU : 40800. BLOCKED QUANTITY/ QUANTITÉ BLOQUÉE : (B)(4). DESCRIPTION : PRINTING DEFECT ON SYRINGES (GRADUATIONS ERASED). PICTURES/PHOTOS: YES/ OUI".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 10ML LL BNS HAD SCALE MARKING PERMANENCY ISSUES BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "PLEASE FIND ATTACHED FORM RFV21.004 FOLLOWING TWO NON-CONFORMITIES DETECTED IN PRODUCTION (SYRINGE GRADUATIONS ERASED) ON: BD SERINGULE 10ML LUER LOCK BULK LUER LOCK. YOUR REFERENCE : 301029. OUR REFERENCE : (B)(4). YOUR LOT : 0127987. OUR LOT: (B)(4). PLEASE INFORM US OF THE CAUSES OF THIS NON-COMPLIANCE AS WELL AS THE CORRECTIVE AND PREVENTIVE ACTIONS TAKEN TO AVOID ANY RECURRENCE. (B)(6) WILL GET BACK TO YOU CONCERNING THE METHODS OF TAKING BACK THE DEFECTIVE GOODS. QUANTITY RECEIVED/ (B)(6). BLOCKED QUANTITY/ (B)(6). DESCRIPTION : PRINTING DEFECT ON SYRINGES (GRADUATIONS ERASED). PICTURES/PHOTOS: YES/(B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170953 SYRINGE 10ML LL BNS PISTON SYRINGE FMI BECTON DICKINSON MEDICAL SYSTEMS 0127987

    Patients

    Seq Age Sex Outcome Treatment
    1