BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 60ML LL TIP 1ML 2 OZ

    MDR report key: 10075893 · Received May 20, 2020

    Report

    Report Number
    2243072-2020-00797
    Event Type
    Malfunction
    Date Received
    May 20, 2020
    Date of Event
    May 7, 2020
    Report Date
    June 29, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE CORRECTED WITH ADDITIONAL INFORMATION: D.4. DEVICE MATERIAL NUMBER: 309653; DEVICE LOT NUMBER: 9303337; UDI NUMBER: (B)(4); DEVICE EXPIRATION DATE: 2024-10-31 D.2. TYPE OF DEVICE: FMF; COMMON DEVICE NAME: PISTON SYRINGE D.1. DEVICE BRAND NAME: SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ G.5. 510K NUMBER: K980987 B.5. EVENT DESCRIPTION: IT WAS REPORTED THAT AN SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ HAD THE PACKAGING TEAR, LEAVING PAPER SHARDS IN THE STERILE FIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT WHEN THE WRAPPING IS PEELED OFF, THERE IS PARTICULATE FROM THE PAPER. CAUSING THE CUSTOMER TO QUESTION THE STERILITY. " H.4. DEVICE CREATION DATE: 2019-10-30

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ HAD THE PACKAGING TEAR, LEAVING PAPER SHARDS IN THE STERILE FIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT WHEN THE WRAPPING IS PEELED OFF, THERE IS PARTICULATE FROM THE PAPER. CAUSING THE CUSTOMER TO QUESTION THE STERILITY. "

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED.  THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. INVESTIGATION CONCLUSION: EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. RATIONALE: CAPA IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD SYRINGE HAD THE PACKAGING TEAR, LEAVING PAPER SHARDS IN THE STERILE FIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT WHEN THE WRAPPING IS PEELED OFF, THERE IS PARTICULATE FROM THE PAPER. CAUSING THE CUSTOMER TO QUESTION THE STERILITY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537501 SYRINGE 60ML LL TIP 1ML 2 OZ PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 9303337

    Patients

    Seq Age Sex Outcome Treatment
    1 Other