MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	8888135132
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, postoperatively, after that catheter was implanted, blood was found to be leaking in the junction/connection between the transparent silicone hose and the red and blue connectors during dialysis.It was stated that the catheter was not repaired, anerdian was the cleaning agent used, tego was not utilized and there was no luer adapter issue.There was no patient injury.
Event or Problem Description
According to the reporter, postoperatively, after that catheter was implanted, blood was found to be leaking in the from the blue tube (venous) transparent silicone hose at the junction during dialysis.It was stated that the catheter has been in place for 3 months.It was sated that the catheter was not repaired, anerdian was the cleaning agent used, tego was not utilized and there was no luer adapter issue.The catheter was replaced.There was blood loss of 4ml.There was no reported patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.A visual inspection of the returned photo noted: the device is being used during a surgical procedure.The blue lumen side is clamped and there is a drop of fluid on the outside of the catheter at the connection sight.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional info: d10, g4, h3, h6 h3 evaluation summary: post market vigilance (pmv) led an evaluation of one device.A visual inspection of the returned product noted: the red port, blue port, clamps, bifurcate and cannula appeared intact.A functional evaluation found that the distal end of the cannula was clamped and a water bath test was performed, air bubbles were detected in the middle of the extension tube on the blue port side.A small hole was observed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the hole in the extension tube may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 8327289
• Report Number: 3009211636-2019-00030
• Device Sequence Number: 19261711
• Product Code: MPB
• UDI-Device Identifier: 20884521006215
• UDI-Public: 20884521006215
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2022
• Device Model Number: 8888135132
• Device Catalogue Number: 8888135132
• Device Lot Number: 1713200096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 02/25/2019; 06/13/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 03/19/2019; 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1