BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE-N AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 11024557 · Received December 16, 2020

    Report

    Report Number
    1710034-2020-00800
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    November 19, 2020
    Report Date
    March 4, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815112
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED FIFTEEN UNOPENED REPRESENTATIVE UNITS FROM LOT NUMBER 0080379. THE RECEIVED UNITS WERE REMOVED FROM THEIR PACKAGES AND VISUALLY INSPECTED FOR DAMAGE TO THE CATHETER. DAMAGE WAS NOT OBSERVED TO ANY OF THE (B)(4) UNITS. A MICROSCOPIC INSPECTION OF THE CATHETER TUBING AND TIP WAS PERFORMED BY CHECKING FOR ANY DEFORMITIES OR BUBBLES/VOIDS TO THE DEVICE. THE CATHETER TIPS WERE GRADED AND FOUND ACCEPTABLE PER SPECIFICATIONS. VENIPUNCTURE WAS PERFORMED ON AN ARTIFICIAL VEIN FOLLOWING THE IFU INSTRUCTIONS TO SEE IF WE COULD REPLICATE THE REPORTED ISSUE. THERE WAS NO SPLITTING OF THE CATHETER THAT OCCURRED. THE RETURNED UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN THE REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETERS FROM LOT 0119474 AND 2 CATHETERS FROM LOT 0080379 SPLINTERED DURING THE INSERTION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I AM WRITING TO INFORM YOU THAT WE HAVE HAD SEVERAL ISSUES WITH THE BD IV CATHETERS SPLINTERING UPON INSERTION. THERE ARE 2 EVENT REPORTS FILED, HOWEVER I HAVE BEEN TOLD OF 2 ADDITIONAL OCCURRENCES OF THIS HAPPENING... WE HAVE SEEN A TREND IN A HIGHER NUMBER OF IV INFILTRATES OCCURRING ON THE UNIT AND IT IS UNCERTAIN IF THE DEFECTED CATHETERS COULD BE A ROOT CAUSE, HOWEVER, IF THEY ARE SPLINTERING/SPLICING THEY COULD POTENTIALLY PERFORATE THE VEIN WALL WITHIN SOME REASONABLE AMOUNT OF TIME."

    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 #: 0119474, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30, DEVICE MANUFACTURE DATE: 2020-05-01. MEDICAL DEVICE LOT #: 0080379, MEDICAL DEVICE EXPIRATION DATE: 2023-02-28, DEVICE MANUFACTURE DATE: 2020-03-24. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD INSYTE-N" AUTOGUARD" SHIELDED IV CATHETERS FROM LOT 0119474 AND 2 CATHETERS FROM LOT 0080379 SPLINTERED DURING THE INSERTION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I AM WRITING TO INFORM YOU THAT WE HAVE HAD SEVERAL ISSUES WITH THE BD IV CATHETERS SPLINTERING UPON INSERTION. THERE ARE 2 EVENT REPORTS FILED, HOWEVER I HAVE BEEN TOLD OF 2 ADDITIONAL OCCURRENCES OF THIS HAPPENING. WE HAVE SEEN A TREND IN A HIGHER NUMBER OF IV INFILTRATES OCCURRING ON THE UNIT AND IT IS UNCERTAIN IF THE DEFECTED CATHETERS COULD BE A ROOT CAUSE, HOWEVER, IF THEY ARE SPLINTERING/SPLICING THEY COULD POTENTIALLY PERFORATE THE VEIN WALL WITHIN SOME REASONABLE AMOUNT OF TIME.."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484465 BD INSYTE-N AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381511 SEE SECTION H.10. 30382903815112

    Patients

    Seq Age Sex Outcome Treatment
    1