BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 7026263 · Received November 13, 2017

    Report

    Report Number
    1710034-2017-00320
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 20, 2017
    Report Date
    October 25, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825333
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: THE CORRECTIVE ACTION STATEMENT IS APPROVED / AUTHORIZED AND FINAL REVIEW OF THE COMPLAINT WILL BE CONDUCTED BY THE DESIGNATED COMPLAINT HANDLING UNIT (DCHU). (B)(4). PART #: 382533 ¿ 20 G X 1.00 IN. (1.1 MM X 25 MM) BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER WITH BLOOD CONTROL TECHNOLOGY. MADE OF BD VIALON CATHETER BIOMATERIAL. HAS BD INSTAFLASH NEEDLE TECHNOLOGY. NON-WINGED. LOT #: 7031794. COMPLAINT:LEAKAGE BEYOND THE SEPTUM; SEPTUM DAMAGED / DEFECTIVE. EVENT DESCRIPTION: WE HAVE HAD SOME ISSUES WITH THE NEW INSYTE AUTOGUARD CATHETERS FROM BD. THEY ARE SUPPOSED TO BE A CLOSED SYSTEM, BUT THERE HAVE NOW BEEN 4 OCCASIONS THAT THE SEAL IS BROKEN FOR NO REASON, GETTING BLOOD EVERYWHERE. IT SEEMS TO BE HAPPENING MORE ON THE 20G SYSTEM, ALTHOUGH IT HAS ALSO OCCURRED WITH THE 22G VERSION. THE LOT NUMBER ASSOCIATED WITH THE 20G SYSTEM IS 7031794. I CANNOT BE 100% SURE WHAT THE LOT IS FOR THE 22G THAT WAS USED. LOT ANALYSIS: DEVICE/BATCH HISTORY RECORD REVIEW: YES. REASON: DHRS ARE AVAILABLE FOR REVIEW AS NEEDED AND ARE REQUIRED FOR QUALITY ISSUES RELATING TO PRODUCT TRACEABILITY OR IF THE REPORTED INCIDENT IS A MEDICAL DEVICE REPORTABLE. FINDINGS: MDR: REVIEW WAS CONDUCTED. LOT 7108520 WAS BUILT AND PACKAGED ON AFA LINE 11 ON 22FEB2017 THRU 28FEB2017 FOR THE QUANTITY OF (B)(4). REVIEWS OF DHRS REVEALED ALL REQUIRED CHALLENGE SAMPLES AND TESTING WAS CONDUCTED PER SPECIFICATIONS AND IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. SAP (QN) DATABASE REVIEW: YES. REASON: THIS DATABASE TRACKS ANY ISSUE DURING PRODUCTION THAT WOULD AFFECT PRODUCT QUALITY. FINDINGS: SUBJECT CODE WAS AN S3 SEVERITY RANKING. REVIEW WAS CONDUCTED FOR THE MDR - LEVEL B INVESTIGATION; AS A RESULT OF THE REVIEWS THERE WERE NO RELATED REJECT ACTIVITY FINDINGS RELEVANT TO THE DEFECT STATED IN THE PIR ASSOCIATED WITH THE LOT NUMBERS PROVIDED FOR THIS INCIDENT. VISUAL ANALYSIS OBSERVATIONS AND TESTING: OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT PROVIDED FOR INVESTIGATION OF THIS INCIDENT. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: UNKNOWN; UNITS WERE NOT PROVIDED FOR OBSERVATION AND TESTING. THE PEURA (END USER RISK ANALYSIS) RM5835 REV 11 VERSION I WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE INVESTIGATION CONCLUSION : CONCLUSIONS: CONFIRMATION OF THE DEFECTS STATED IN THE PIR COULD NOT BE IDENTIFIED OR CONFIRMED AND CAUSE COULD NOT BE DETERMINED, AS THE UNITS DESCRIBED IN THE PRODUCT INCIDENT REPORT WERE NOT PROVIDED FOR EVALUATION AND TESTING. THEREFORE, THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECTS STATED IN THE PIR. THIS INCIDENT IS INDETERMINATE. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? N/A; UNABLE TO CONFIRM THE CUSTOMER¿S EXPERIENCE BECAUSE UNITS WERE NOT PROVIDED FOR EVALUATION AND TESTING. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? N/A; UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE BECAUSE UNITS WERE NOT PROVIDED FOR EVALUATION AND TESTING. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT. ROOT CAUSE DESCRIPTION : RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE. COMMENT: UNITS NOT PROVIDED FOR INVESTIGATION OF THE INCIDENT STATED IN THE PIR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER MALFUNCTIONED DURING USE AS THE SEAL BROKE, RESULTING IN BLOOD EXPOSURE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803283 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7031794 30382903825333

    Patients

    Seq Age Sex Outcome Treatment
    1 Other