BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL

    MDR report key: 9167953 · Received October 8, 2019

    Report

    Report Number
    9614033-2019-00251
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    September 7, 2019
    Report Date
    December 26, 2019
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE RECEIVED FOR INVESTIGATION, UPON OBSERVATION A LINE OF INK CAN BE SEEN ON THE PACKAGING PAPER. THE SAMPLES SENT BY THE CLIENT HAVE INK STAINS ON THE BLISTER PAPER, WHICH MAY BE RELATED TO INK REMNANTS. DURING THE DOCUMENTARY INVESTIGATION, NO QUALITY EVENTS WERE GENERATED THAT COULD BE ATTRIBUTABLE TO THE DEFECT REPORTED, HOWEVER, THE DAMAGE CAN BE GENERATED DURING THE PACKING DUE TO DAMAGE TO THE INKWELL'S RAZOR BLADES, IT IS WORTH MENTIONING THAT THE NUMBER OF DEFECTIVE PARTS REPORTED BY THE CUSTOMER IS WITHIN THE LEVEL OF QUALITY ACCEPTANCE. THE LOT WAS INSPECTED ACCORDING TO THE CURRENT WORK INSTRUCTION WITH SATISFACTORY RESULTS FOR THE CHARACTERISTICS REQUIRED FOR ITS APPROVAL INCLUDING FUNCTIONAL TESTS. NO NON-CONFORMING PART THAT COULD BE ATTRIBUTABLE TO THE DEFECT REPORTED BY THE CLIENT WAS PRESENTED. NO DEVIATIONS (QUALITY NOTIFICATIONS) WERE REPORTED DURING THE MANUFACTURING PROCESS. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE CUSTOMER CLARIFIED THE AFFECTED QUANTITY OF PRODUCT AND WHICH LOTS WERE AFFECTED. LOTS 9048608 AND 8186612 WERE NOT INVOLVED IN THE EVENT. THE FOLLOWING FIELDS HAVE BEEN UPDATED: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 13 SEPARATE SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDLS HAD DISCOLORED BLISTER PACKAGING THAT WAS FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: "STAINED SYRINGE." MEDICAL DEVICE LOT#: 9048609. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2019-04-08.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 13 SEPARATE SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDLS HAD DISCOLORED BLISTER PACKAGING THAT WAS FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: "STAINED SYRINGE"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 13 SEPARATE SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDLS HAD DISCOLORED BLISTER PACKAGING THAT WAS FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: "STAINED SYRINGE."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9048609, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: 2019-04-08. MEDICAL DEVICE LOT #: 9048608, MEDICAL DEVICE EXPIRATION DATE: 2024-02-28, DEVICE MANUFACTURE DATE: 2019-04-09. MEDICAL DEVICE LOT #: 8186612, MEDICAL DEVICE EXPIRATION DATE: 2023-07-31, DEVICE MANUFACTURE DATE: 2018-08-27. 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 SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL BLISTER PACKAGING WAS FOUND DISCOLORED BEFORE USE. LOT# 9048608 WAS REPORTED TO HAVE 15 OCCURRENCES OF THIS EVENT, WHILE LOTS 9048609 AND 8186612 HAD AN UNSPECIFIED NUMBER OF OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: "STAINED SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959304 SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL SYRINGE FMF BECTON DICKINSON DE MEXICO 9048609

    Patients

    Seq Age Sex Outcome Treatment
    1 Other