BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 7747674 · Received August 3, 2018

    Report

    Report Number
    1213809-2018-00478
    Event Type
    Malfunction
    Date Received
    August 3, 2018
    Date of Event
    July 12, 2018
    Report Date
    August 15, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: NO.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO PHOTOS WERE RECEIVED AND EVALUATED. NO PHYSICAL SAMPLES WERE RECEIVED. THE FIRST PHOTO DEPICTS 13 SYRINGES WITH MISSING PRINT, REPORTED TO BE FROM BATCH#: 8011982. THE MISSING PRINT AFFECTS ITEMS BETWEEN THE 2ML AND BD LOGO MARKINGS. THE PRINT APPEARS TO HAVE BEEN SCRATCHED OFF IN AT LEAST A FEW OF THE VISIBLE SAMPLES. THE MISSING PRINT OBSERVED IS REJECTABLE PER PRODUCT SPECIFICATION. THE SECOND PHOTO DEPICTS 7 SYRINGES WITH VISIBLE DAMAGE TO THE BARRELS. SIX OF THE SEVEN SYRINGES HAVE DIAGONAL SCRATCHES AND/OR SCUFF MARKS BETWEEN APPROXIMATELY THE 1ML MARKING AND THE LUER COLLAR ON THE BARRELS. BASED ON THE PHOTO IT IS DIFFICULT TO DETERMINE IF THE DAMAGE IS REJECTABLE OR COSMETIC. SOME OF THE SYRINGES MAY BE ACCEPTABLE PER PRODUCT SPECIFICATION. PHYSICAL SAMPLES WOULD BE REQUIRED FOR DETERMINATION. FURTHERMORE, ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT FOR BOTH LOT NUMBERS. MACHINE LOGS REVIEW INDICATES ISSUES WERE OBSERVED WITH SYRINGE TRANSFER SYSTEM AT ASSEMBLY DURING THE MANUFACTURE OF BATCH: 8002811. ISSUES WERE CORRECTED BY QUALIFIED TECHS AT THE TIME THEY WERE DISCOVERED AND RECORDED. ASSEMBLY DIAL JAMS WERE RECORDED DURING THE MANUFACTURE OF BATCH: 8011982. THEY WERE ADDRESSED AT THE TIME OF OCCURRENCE. INVESTIGATION CONCLUSION: PROBABLE ROOT CAUSE: BATCH: 8002811. DAMAGE TO BARREL (SCRATCH): THE SCRATCH WAS LIKELY DUE TO THE ISSUES WITH THE SYRINGE TRANSFER SYSTEM AT ASSEMBLY RECORDED DURING THE MANUFACTURE OF THE BATCH. BATCH: 8011982. MISSING PRINT: THE PRINT WAS LIKELY SCRATCHED OFF BY A PIECE OF JAMMED COMPONENT DURING AN ASSEMBLY DIAL JAM. CORRECTIVE ACTIONS: NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE HAD ILLEGIBLE PRINT. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE HAD ILLEGIBLE PRINT. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8002811, MEDICAL DEVICE EXPIRATION DATE: 2022-12-31, DEVICE MANUFACTURE DATE: 2018-01-02. MEDICAL DEVICE LOT #: 8011982, MEDICAL DEVICE EXPIRATION DATE: 2022-12-31, DEVICE MANUFACTURE DATE: 2018-01-11. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE HAD ILLEGIBLE PRINT. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587560 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other