BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-CENTESIS TRAY 6FR X 16CM

    MDR report key: 19990967 · Received August 15, 2024

    Report

    Report Number
    1625685-2024-00095
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    July 12, 2024
    Report Date
    November 13, 2024
    Manufacturer
    CAREFUSION, INC
    Product Code
    PXI
    UDI-DI
    10885403108365
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A050402. PATIENT PROBLEM CODE: F26.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW-UP EMDR FOR DEVICE EVALUATION: ONE CATHETER AND DRAINAGE LINE WERE RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A CRACK IN THE STOPCOCK ATTACHED TO THE CATHETER OBSERVED; THEREFORE, THE REPORTED FAILURE COULD BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER 0001548376 WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. PRODUCT UNDERGOES INSPECTIONS DURING MANUFACTURING, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED, ALL PROCEDURAL AND FUNCTIONAL REQUIREMENTS FOR PRODUCT RELEASE HAVE BEEN MET. BASED ON THE QUALITY TEAM'S INVESTIGATION, A SUPPLIER FAILURE WAS CONFIRMED. A QUALITY NOTIFICATION HAS BEEN SENT TO THE SUPPLIER TO RAISE AWARENESS. IN ADDITION, AWARENESS TRAINING HAS BEEN PERFORMED WITH THE INCOMING INSPECTION TEAM. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. DURING THE INVESTIGATION, THE SAMPLE ANALYSIS DETERMINED THAT THE ISSUE WITH THE PRODUCT WAS A CRACK IN THE STOPCOCK ATTACHED TO THE CATHETER. SAMPLE INVESTIGATION LED TO A CHANGE IN THE MALFUNCTION. AS ANALYZED CODE DIFFERING FROM THE AS REPORTED CODE. IMDRF ANNEX A GRID HAS BEEN UPDATED TO A0404 CRACK (1135).

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT THEY HAVE AN AIR LEAK IN THE WHITE CONNECTOR WHERE THE NEEDLE IS REMOVED AFTER INSERTED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ITEM: PIG1260T QUANTITY AFFECTED: 1 EA SERIAL/LOT NUMBER: (B)(6). PO: (B)(6). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES REPORTED ISSUE: WE HAD AN EVENT THIS MORNING WHERE WE SEEMED TO HAVE AN AIR LEAK IN THE WHITE CONNECTOR WHERE THE NEEDLE IS REMOVED AFTER INSERTED. CUSTOMER RESPONSE RECEIVED ON 07AUG. 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? - PT. CAME IN FOR A PARACENTESIS. ONCE PHYSICIAN INSERTED THE DEVICE, THERE SEEMED TO BE AN AIR LEAK, WHERE ARE WAS GETTING INTO THE TUBING AND INTO THE EVAC CONTAINER. THE AIR LEAKED APPEARED TO BE COMING AT OF THE WHITE CONNECTOR WHERE THE NEEDLE IS REMOVED AFTER INSERTED. THE PRODUCT USED WAS SAFE-T-CENTESIS 6 FR CATHETER DRAINAGE TRAY LOT NO. 0001548376. THIS CAUSED THE PROCEDURE TO TAKE LONGER. 2. DID THE ISSUE HAPPEN DURING PATIENT USE AND THE PRODUCT DISCARDED OR DID THEY IDENTIFY THE AIR LEAKAGE DURING USE? ¿ DURING USE ¿ PRODUCT RETURNED TO VENDOR PER YOUR REQUEST. 3. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? ¿ DIRECTLY 4. WHAT WAS THE IMPACT TO THE PATIENT? ¿ LONGER PROCEDURE TIME. 5. WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? ¿ TREATMENT DELAY AS IT TOOK LONGER TO REMOVE THE FLUID. 6. HOW WAS THE ISSUE RESOLVED? ¿ WE APPLIED A TEGADERM OVER THE AIR LEAK RATHER THAN PUNCTURING THE PATIENT AGAIN AND INCREASING CHANCE OF INFECTION. 7. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN DD-MMM-YYYY FORMAT? ¿ 12-07-2024 8. WAS THERE ANY DAMAGE OR VISIBLE DEFECT WITH THE PRODUCT? ¿ WE DIDN¿T VISUALLY SEE IT AND DIDN¿T NOTICE IT UNTIL WE STARTED THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT THEY HAVE AN AIR LEAK IN THE WHITE CONNECTOR WHERE THE NEEDLE IS REMOVED AFTER INSERTED. REPORTED ISSUE: WE HAD AN EVENT THIS MORNING WHERE WE SEEMED TO HAVE AN AIR LEAK IN THE WHITE CONNECTOR WHERE THE NEEDLE IS REMOVED AFTER INSERTED. CUSTOMER RESPONSE RECEIVED ON 07AUG: 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? - PT. CAME IN FOR A PARACENTESIS. ONCE PHYSICIAN INSERTED THE DEVICE, THERE SEEMED TO BE AN AIR LEAK, WHERE ARE WAS GETTING INTO THE TUBING AND INTO THE EVAC CONTAINER. THE AIR LEAKED APPEARED TO BE COMING AT OF THE WHITE CONNECTOR WHERE THE NEEDLE IS REMOVED AFTER INSERTED. THE PRODUCT USED WAS SAFE-T-CENTESIS 6 FR CATHETER DRAINAGE TRAY LOT NO. 0001548376. THIS CAUSED THE PROCEDURE TO TAKE LONGER. 2. DID THE ISSUE HAPPEN DURING PATIENT USE AND THE PRODUCT DISCARDED OR DID THEY IDENTIFY THE AIR LEAKAGE DURING USE? ¿ DURING USE ¿ PRODUCT RETURNED TO VENDOR PER YOUR REQUEST. 3. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? ¿ DIRECTLY. 4. WHAT WAS THE IMPACT TO THE PATIENT? ¿ LONGER PROCEDURE TIME. 5. WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? ¿ TREATMENT DELAY AS IT TOOK LONGER TO REMOVE THE FLUID. 6. HOW WAS THE ISSUE RESOLVED? ¿ WE APPLIED A TEGADERM OVER THE AIR LEAK RATHER THAN PUNCTURING THE PATIENT AGAIN AND INCREASING CHANCE OF INFECTION. 7. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN DD-MMM-YYYY FORMAT? ¿ 12-07-2024. 8. WAS THERE ANY DAMAGE OR VISIBLE DEFECT WITH THE PRODUCT? ¿ WE DIDN¿T VISUALLY SEE IT AND DIDN¿T NOTICE IT UNTIL WE STARTED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094362 SAFE-T-CENTESIS TRAY 6FR X 16CM THORACENTESIS TRAY PXI CAREFUSION, INC 0001548376 10885403108365

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other