BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 9225073 · Received October 23, 2019

    Report

    Report Number
    1213809-2019-01067
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Date of Event
    October 8, 2019
    Report Date
    February 12, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SEVEN 3ML SEALED PACKAGED SYRINGES WERE RECEIVED, CONFIRMED TO BE FROM BATCH #9130794 (P/N 309657). THEY WERE VISUALLY EVALUATED. THE BARRELS WERE OBSERVED TO HAVE VARYING DEGREES OF MISSING SCALE PRINT BETWEEN THE LOGO AND 1ML MARKING. NO SAMPLES WERE RECEIVED FROM BATCH 9140840. THE MISSING PRINT OBSERVED WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS AND WITH FAILURE TO CONTAIN DEFECT. DHR WAS PERFORMED. A QUALITY NOTIFICATION WAS ISSUED FOR MISSING PRINT DURING THE MANUFACTURE OF THIS BATCH. ADJUSTMENTS WERE MADE, LINE CLEARED AND PRODUCT REQUALIFIED PER APPLICABLE AQL BEFORE PRODUCTION RESUMED. BATCH 9130794 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 3ML LL 200 S/C EXPERIENCED MISSING SCALE MARKINGS WHICH WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657, BATCH NO: 9130794, 9140840. PRODUCT CATALOG NUMBER: 309657. PRODUCT DESCRIPTION: SYRINGE 3ML LF STRL GRAD N-PYRG LL DEHP-FR PVC FREE MED DISP ORIGIN OF THE ISSUE: PATIENT SAFETY. DETAIL: 3ML SYRINGE PART# 309657, LOT# 9130794 IS DEFECTIVE. THE MEASUREMENT SCALE PRINTED ON THE SYRINGE IS INCOMPLETE. NUMBER OF OCCURRENCES: 3.0. LOT NUMBER: 9140840.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9130794, MEDICAL DEVICE EXPIRATION DATE: 2024-04-30, DEVICE MANUFACTURE DATE: 2019-05-10. MEDICAL DEVICE LOT #: 9140840, MEDICAL DEVICE EXPIRATION DATE: 2024-04-30, DEVICE MANUFACTURE DATE: 2019-05-20.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 3ML LL 200 S/C EXPERIENCED MISSING SCALE MARKINGS WHICH WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 BATCH NO: 9130794, 9140840. PRODUCT CATALOG NUMBER: 309657. PRODUCT DESCRIPTION: SYRINGE 3ML LF STRL GRAD N-PYRG LL DEHP-FR PVC FREE MED DISP ORIGIN OF THE ISSUE: PATIENT SAFETY. DETAIL: 3ML SYRINGE PART# 309657, LOT# 9130794 IS DEFECTIVE. THE MEASUREMENT SCALE PRINTED ON THE SYRINGE IS INCOMPLETE. NUMBER OF OCCURRENCES: 3.0. LOT NUMBER: 9140840.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024702 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 SEE H.10 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other