BEUDAMED
    FDA Adverse Event Injury Summary report: N

    16G X 1.16IN (1.7 X 30 MM) ANGIOCATH

    MDR report key: 9256508 · Received October 30, 2019

    Report

    Report Number
    9610847-2019-00653
    Event Type
    Injury
    Date Received
    October 30, 2019
    Date of Event
    October 5, 2019
    Report Date
    December 27, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 6063764, 7051295, AND 4325585. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN ANY OF THESE PRODUCTION BATCHES. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THESE LOTS WERE ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY PULL FORCE TESTING WAS CONDUCTED ON THE REPRESENTATIVE SAMPLES SUBMITTED. TESTING RESULTS FOR THE REPRESENTATIVE SAMPLES MET PRODUCT SPECIFICATIONS, UNFORTUNATELY, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER BROKE DURING USE WITH A 16G X 1.16IN (1.7 X 30 MM) ANGIOCATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING THE REMOVAL OF THE CATHETER THEY REALIZED THAT A PART OF IT REMAINED IN THE VEIN. AN URGENT ULTRASOUND SCAN WAS PERFORMED AND THE BROKEN CATHETER WAS REMOVED BY A SURGICAL INTERVENTION. THE LIST OF MEDICINES THAT WAS USED WITH THE CATHETER: CEFAMEZIN IV 1FL 1G+F 10 ML, TRANEX OS IV 6F 5 ML 500 MG, CEFAZOLINA TEVA IV F 1G+F 10 ML, ELETTROLITICA REINTEGRO NA 20 SACC 500 ML, SODIO CLORURO 0.9 %, FLEXEN IV 6F 100 MG+6 F 5 ML, PLASIL INIETTABILE 5F 10MG/2ML, MORFINA CL 5F 1ML 10MG/ML, PERFALGAN EV 10MG/ML 100 ML."

    Additional Manufacturer Narrative · 1

    THE LOT# IS UNKNOWN BUT THE CUSTOMER PROVIDED 3 POSSIBLE LOT#S. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6063764; EXPIRATION DATE: 2021-03-31; MANUFACTURE DATE: 2016-04-04. MEDICAL DEVICE LOT #: 4325585; EXPIRATION DATE: 2019-12-31; MANUFACTURE DATE: 2015-01-05. THE REPORTED LOT# 7051292 WAS NOT FOUND FOR THE CATALOG NUMBER. 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 A CATHETER BROKE DURING USE WITH A 16G X 1.16IN (1.7 X 30 MM) ANGIOCATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING THE REMOVAL OF THE CATHETER THEY REALIZED THAT A PART OF IT REMAINED IN THE VEIN. AN URGENT ULTRASOUND SCAN WAS PERFORMED AND THE BROKEN CATHETER WAS REMOVED BY A SURGICAL INTERVENTION. THE LIST OF MEDICINES THAT WAS USED WITH THE CATHETER: CEFAMEZIN IV 1FL 1G+F 10 ML; TRANEX OS IV 6F 5 ML 500 MG; CEFAZOLINA TEVA IV F 1G+F 10 ML; ELETTROLITICA REINTEGRO NA 20 SACC 500 ML; SODIO CLORURO 0.9 %; FLEXEN IV 6F 100 MG+6 F 5 ML; PLASIL INIETTABILE 5F 10MG/2ML; MORFINA CL 5F 1ML 10MG/ML; PERFALGAN EV 10MG/ML 100 ML."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049271 16G X 1.16IN (1.7 X 30 MM) ANGIOCATH INTERVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention