BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON LATEX AIR RETENTION TIP

    MDR report key: 7143193 · Received December 22, 2017

    Report

    Report Number
    2411512-2017-00001
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    November 24, 2017
    Report Date
    November 24, 2017
    Manufacturer
    E-Z-EM INC.
    Product Code
    FGD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 2017: BRACCO DISTRIBUTOR REPORTED THAT THERE IS A HARD PIECE STICKING OUT OF THE NON LATEX AIR RETENTION TIP WHICH COULD CAUSE SERIOUS INJURY TO THE PATIENT. THERE WERE 2 CASES THAT WERE INSPECTED AND BOTH CASES HAD THE SAME DEFECT. THE DISTRIBUTOR REPORTED THERE HAS BEEN NO REPORTS OF ANY INCIDENTS WITH ANY PATIENTS. 15-DEC-2017: BRACCO QUALITY INVESTIGATION RESULTS BECAME AVAILABLE. CONCLUSION: BASED IN THE REVISION OF THE DEVICE HISTORY RECORD (DHR) OF THE RELATED LOT NUMBERS FOR SUBASSEMBLIES AND FINISH GOOD, NO DEVIATIONS, NON-CONFORMANCES AND ISSUES WERE FOUND RELATED TO THE REPORTED FAILURE. AFTER EVALUATION THE DEFECT HARDENED THREAD WAS CONFIRMED ON THE RECEIVED SAMPLE. THE ANALYSIS OF THE SOURCES OF VARIATION FOR VISUAL INSPECTION NOT PERFORMED, LACK OF TRAINING, INSPECTION NOT STATED IN THE PROCEDURE AND TURN OF THREAD NOT PERFORMED, THESE POSSIBLE FACTORS WERE PREVIOUSLY MITIGATED BY ACTIONS IMPLEMENTED ON 15-JUN-2017. THE DEFECTIVE DEVICES WERE MANUFACTURED BEFORE 15-JUN-2017, WHEN MITIGATION ACTIVITIES WERE NOT IN PLACE YET. SINCE THERE HAVE BEEN ACTIONS IMPLEMENTED TO MITIGATE THIS FAILURE MODE, NO CAPA WILL BE CREATED AND NO ADDITIONAL ACTIONS WILL BE IMPLEMENTED AT THIS MOMENT. COMPANY COMMENTS: THIS IS A DEVICE MALFUNCTION WITH THE USE OF THE NON LATEX AIR RETENTION TIP. THE DISTRIBUTOR REPORTED THAT THERE WAS A HARD PIECE STICKING OUT OF THE NON LATEX AIR RETENTION TIP WHICH COULD CAUSE SERIOUS INJURY TO THE PATIENT DURING INSERTION. THERE WAS NO PATIENT OR USER/OPERATOR INJURY. HOWEVER THERE MAY BE THE POTENTIAL OF INJURY, IF THE ISSUE WAS TO REOCCUR. QUALITY INVESTIGATION CONFIRMED THAT BASED ON REVIEW OF THE DEVICE HISTORY RECORD (DHR) OF THE RELATED LOT NUMBERS FOR SUBASSEMBLIES AND FINISH GOOD, NO DEVIATIONS, NON-CONFORMANCES AND ISSUES WERE FOUND RELATED TO THE REPORTED FAILURE. ANALYSIS OF THE SOURCES OF VARIATION FOR: VISUAL INSPECTION NOT PERFORMED, LACK OF TRAINING, NEEDED INSPECTION NOT STATED IN PROCEDURE AND TURN OF THREAD NOT PERFORMED ARE POSSIBLE FACTORS THAT WERE PREVIOUSLY MITIGATED BY ACTIONS IMPLEMENTED ON JUNE 15, 2017. SINCE THE DEFECTIVE DEVICES WERE MANUFACTURED BEFORE JUNE 15TH 2017, WHEN MITIGATION ACTIVITIES WERE NOT YET IN PLACE TO MITIGATE THIS FAILURE MODE, NO CAPA WILL BE CREATED AND NO ADDITIONAL ACTIONS WILL BE IMPLEMENTED AT THIS TIME.

    Description of Event or Problem · 0

    ON (B)(6) 2017, THE BRACCO (B)(4) AFFILIATE RECEIVED A PRODUCT COMPLAINT FROM A BRACCO DISTRIBUTOR ((B)(4)) IN (B)(4). ON 27-NOV-2017, THE REPORT WAS FORWARDED TO BDI DRUG SAFETY VIA EMAIL. THE DISTRIBUTOR ((B)(4)) REPORTED THAT THERE WAS A DEFECT DESCRIBED AS A HARD PIECE STICKING OUT OF THE NON LATEX AIR RETENTION TIP WHICH COULD CAUSE SERIOUS INJURY TO THE PATIENT. THERE WERE 2 CASES THAT WERE INSPECTED BY THE DISTRIBUTOR AND BOTH CASES HAD THE SAME DEFECT. THE DISTRIBUTOR REPORTED THERE HAVE BEEN NO REPORTS OF ANY INCIDENTS WITH ANY PATIENTS. NO FURTHER INFORMATION WAS AVAILABLE FOR THIS REPORT. ON 15-DEC-2017, BRACCO QUALITY INVESTIGATION RESULTS BECAME AVAILABLE. THIS CASE IS MEDICALLY CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    ON 24-NOV-2017: BRACCO DISTRIBUTOR REPORTED THAT THERE IS A HARD PIECE STICKING OUT OF THE NON LATEX AIR RETENTION TIP WHICH COULD CAUSE SERIOUS INJURY TO THE PATIENT. THERE WERE 2 CASES THAT WERE INSPECTED AND BOTH CASES HAD THE SAME DEFECT. THE DISTRIBUTOR REPORTED THERE HAS BEEN NO REPORTS OF ANY INCIDENTS WITH ANY PATIENTS. ON 15-DEC-2017: BRACCO QUALITY INVESTIGATION RESULTS BECAME AVAILABLE. CONCLUSION: BASED IN THE REVISION OF THE DEVICE HISTORY RECORD (DHR) OF THE RELATED LOT NUMBERS FOR SUBASSEMBLIES AND FINISH GOOD, NO DEVIATIONS, NON-CONFORMANCES AND ISSUES WERE FOUND RELATED TO THE REPORTED FAILURE. AFTER EVALUATION THE DEFECT HARDENED THREAD WAS CONFIRMED ON THE RECEIVED SAMPLE. THE ANALYSIS OF THE SOURCES OF VARIATION FOR VISUAL INSPECTION NOT PERFORMED, LACK OF TRAINING, INSPECTION NOT STATED IN THE PROCEDURE AND TURN OF THREAD NOT PERFORMED, THESE POSSIBLE FACTORS WERE PREVIOUSLY MITIGATED BY ACTIONS IMPLEMENTED ON 15-JUN-2017. THE DEFECTIVE DEVICES WERE MANUFACTURED BEFORE 15-JUN-2017, WHEN MITIGATION ACTIVITIES WERE NOT IN PLACE YET. SINCE THERE HAVE BEEN ACTIONS IMPLEMENTED TO MITIGATE THIS FAILURE MODE, NO CAPA WILL BE CREATED AND NO ADDITIONAL ACTIONS WILL BE IMPLEMENTED AT THIS MOMENT. COMPANY COMMENTS: THIS IS A DEVICE MALFUNCTION WITH THE USE OF THE NON LATEX AIR RETENTION TIP. THE DISTRIBUTOR REPORTED THAT THERE WAS A HARD PIECE STICKING OUT OF THE NON LATEX AIR RETENTION TIP WHICH COULD CAUSE SERIOUS INJURY TO THE PATIENT DURING INSERTION. THERE WAS NO PATIENT OR USER/OPERATOR INJURY. HOWEVER THERE MAY BE THE POTENTIAL OF INJURY, IF THE ISSUE WAS TO REOCCUR. QUALITY INVESTIGATION CONFIRMED THAT BASED ON REVIEW OF THE DEVICE HISTORY RECORD (DHR) OF THE RELATED LOT NUMBERS FOR SUBASSEMBLIES AND FINISH GOOD, NO DEVIATIONS, NON-CONFORMANCES AND ISSUES WERE FOUND RELATED TO THE REPORTED FAILURE. ANALYSIS OF THE SOURCES OF VARIATION FOR: VISUAL INSPECTION NOT PERFORMED, LACK OF TRAINING, NEEDED INSPECTION NOT STATED IN PROCEDURE AND TURN OF THREAD NOT PERFORMED ARE POSSIBLE FACTORS THAT WERE PREVIOUSLY MITIGATED BY ACTIONS IMPLEMENTED ON JUNE 15, 2017. SINCE THE DEFECTIVE DEVICES WERE MANUFACTURED BEFORE JUNE 15TH 2017, WHEN MITIGATION ACTIVITIES WERE NOT YET IN PLACE TO MITIGATE THIS FAILURE MODE, NO CAPA WILL BE CREATED AND NO ADDITIONAL ACTIONS WILL BE IMPLEMENTED AT THIS TIME.

    Description of Event or Problem · 1

    ON 24-NOV-2017, THE BRACCO (B)(6) AFFILIATE RECEIVED A PRODUCT COMPLAINT FROM A BRACCO DISTRIBUTOR (B)(4). ON 27-NOV-2017, THE REPORT WAS FORWARDED TO (B)(4) DRUG SAFETY VIA EMAIL. THE DISTRIBUTOR (B)(4) REPORTED THAT THERE WAS A DEFECT DESCRIBED AS A HARD PIECE STICKING OUT OF THE NON LATEX AIR RETENTION TIP WHICH COULD CAUSE SERIOUS INJURY TO THE PATIENT. THERE WERE 2 CASES THAT WERE INSPECTED BY THE DISTRIBUTOR AND BOTH CASES HAD THE SAME DEFECT. THE DISTRIBUTOR REPORTED THERE HAVE BEEN NO REPORTS OF ANY INCIDENTS WITH ANY PATIENTS. NO FURTHER INFORMATION WAS AVAILABLE FOR THIS REPORT. ON 15-DEC-2017, BRACCO QUALITY INVESTIGATION RESULTS BECAME AVAILABLE. THIS CASE IS MEDICALLY CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923797 NON LATEX AIR RETENTION TIP ENEMA TIP FGD E-Z-EM INC. 50872263, 50872264

    Patients

    Seq Age Sex Outcome Treatment
    1