BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML BD¿ CLEAR BARREL ORAL SYRINGE

    MDR report key: 7024473 · Received November 13, 2017

    Report

    Report Number
    1213809-2017-00261
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 19, 2017
    Report Date
    January 15, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT NUMBER: MEDICAL DEVICE LOT #: 7208612, MEDICAL DEVICE EXPIRATION DATE: 9/7/2017, DEVICE MANUFACTURE DATE: 7/27/2017. INVESTIGATION SUMMARY: FOUR LOOSE 1ML SYRINGES WERE RECEIVED BY BD (B)(4). THREE SAMPLES WERE REPORTED TO BE FROM THE BATCH 7116942, WHILE ONE SAMPLE IS FROM BATCH 7208612. ALL FOUR SYRINGES WERE CONTAINED IN INDIVIDUAL SAMPLE BAGS. THE SAMPLES WERE VISUALLY EVALUATED. BATCH 7116942: "FIRST BULLET POINT" HAD LIGHT MISSING PRINT ON THE SCALE MARKINGS DUE TO CUSTOMER HANDLING AS SPECIFIED IN THE COMPLAINT DESCRIPTION. "FOR ORAL USE ONLY" WAS UNAFFECTED. "SECOND BULLET POINT" HAD MAJOR MISSING PRINT OF THE SCALE MARKINGS AND "FOR ORAL USE ONLY" SIGN DUE TO CUSTOMER HANDLING. "LAST BULLET POINT" SAMPLE WAS IN A SEALED BAG CONTAINING A PIBA- HAD NO VISUAL DEFECTS. BATCH 7208612: "THIRD BULLET POINT" SAMPLE HAD NO VISUAL DEFECTS. THE SYRINGES MANUFACTURED AT BD (B)(4) ARE TESTED FOR PRINT PERMANENCY WITH ISOPROPYL ALCOHOL AND A COTTON SWAB DURING MANUFACTURING. THREE OF FOUR SAMPLES RECEIVED WERE TESTED USING THE TEST FOR PRINT PERMANENCY. THE "SECOND BULLET POINT" SAMPLE WAS EXCLUDED DUE TO ALREADY HAVING MAJOR MISSING PRINT FROM PRIOR REPORTED TESTING AND THE REPORTED PRESENCE OF LOTION SUBSTANCE THAT COULD POTENTIALLY INTERFERE WITH THE TEST. RESULTS: "FIRST BULLET POINT" SAMPLE- TEST PERFORMED ON THE "FOR ORAL USE ONLY" PART OF THE SCALE MARKINGS AS THAT WAS THE UNAFFECTED PART OF THE SCALE STILL PRESENT IN THE SAMPLE. TEST RESULT: PASS WITH NO INK COMING OFF. "LAST BULLET POINT" SAMPLE- ENTIRE SCALE WAS TESTED. TEST RESULT: PASS WITH NO INK COMING OFF. "THIRD BULLET POINT" SAMPLE- ENTIRE SCALE WAS TESTED. TEST RESULT: PASS WITH NO INK COMING OFF. INVESTIGATION CONCLUSION: BASED ON THE DHR/QN REVIEW AND ON THE SAMPLE EVALUATION AND TESTING PERFORMED, NO DEFECTS COULD BE CONFIRMED TO BE PRESENT IN THE BATCH 7116942 PERTAINING TO INK PERMANENCY. THE PRODUCT IS MANUFACTURED IN ACCORDANCE WITH ISO 7886-1 AND OUR PRODUCT SPECIFICATION. BASED ON THE SAMPLE EVALUATION: UNCONFIRMED: BD CANAAN WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON THE TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE OF THE 1 ML BD¿ CLEAR BARREL ORAL SYRINGE THE SCALE MARKINGS ARE RUBBING OFF. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803084 1 ML BD¿ CLEAR BARREL ORAL SYRINGE ORAL SYRINGE KYW BECTON DICKINSON MEDICAL SYSTEMS 7116942

    Patients

    Seq Age Sex Outcome Treatment
    1 Other