BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BC

    MDR report key: 6792959 · Received August 14, 2017

    Report

    Report Number
    1710034-2017-00136
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Date of Event
    May 25, 2017
    Report Date
    September 11, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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). PR #: 113040 ¿ 122765 CR ¿ MDR- NO SAMPLE PART #: 382534 ¿ 20 G X 1.16 IN. (1.1 MM X 30 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 #: 7060704 COMPLAINT: CATHETER TIP INTEGRITY. EVENT DESCRIPTION: WHEN PREPARING TO START AN IV ON A SURGICAL PATIENT, VISUAL INSPECTION OF THE ANGIOCATH PRIOR TO INSERTION REVEALED A FLECK OF PLASTIC AT THE TIP OF THE ANGIOCATH. 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 7060704 WAS BUILT ON AFA LINE 11 AND PACKAGED ON LINE 11 ON 05MAR2017 THRU 08MAR2017 FOR THE QUANTITY OF 396,010EA. REVIEW OF DHR 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 S1 SEVERITY RANKING. REVIEW WAS CONDUCTED FOR THE LEVEL A INVESTIGATION; AS A RESULT OF THE REVIEW THERE WERE NO REJECT ACTIVITY FINDINGS RELEVANT TO THE DEFECT STATED IN THE PR ASSOCIATED TO THE LOT NUMBER PROVIDED FOR THIS INCIDENT. OBSERVATIONS AND TESTING: OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION OF THIS INCIDENT. TEST DESCRIPTION METHOD NO RESULTS N/A N/A N/A INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: UNKNOWN; UNITS WERE NOT RECEIVED FOR OBSERVATION AND TESTING. INVESTIGATION CONCLUSION: CONCLUSIONS: CONFIRMATION OF THE DEFECT STATED IN THE PR COULD NOT BE IDENTIFIED OR CONFIRMED AND CAUSE COULD NOT BE DETERMINED, AS THE UNIT DESCRIBED IN THE PRODUCT INCIDENT REPORT WAS NOT RETURNED 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 RETURNED 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 RETURNED 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 PR. RATIONALE: CORRECTIVE ACTION PROJECT / CAPA (#): A ROOT CAUSE COULD NOT BE ESTABLISHED. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME. OTHER ACTION TAKEN: PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS AND/OR PROCESS CONTROL TECHNICIANS TO ENSURE ANY GROSS PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED, DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION ARE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN. THE PEURA (END USER RISK ANALYSIS) (B)(4) VERSION I WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY CONSUMER THAT WHEN PREPARING TO START AN IV ON A SURGICAL PATIENT, A VISUAL INSPECTION WAS PERFORMED PRIOR TO INSERTING A 20 G X 1.16 IN. (1.1 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BC. THE INSPECTION REVEALED A FLECK OF PLASTIC AT THE TIP OF THE ANGIOCATH. NO INJURY OR MEDICAL INTERVENTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571198 20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BC INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7060704

    Patients

    Seq Age Sex Outcome Treatment
    1 Other