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

Model Number	8888145039
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2019
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, during the procedure, the catheter was found to be leaking from the clear tubing on the brown line.There were two pinholes found in the silicone tubing and flushing was recommended to see the holes.As a result, the catheter was removed and another catheter was inserted to resolve the issue.There was no leaking at the junction of the bifurcate and catheter, there was no luer adapter issue and the insertion site was treated with chloroprep prior to product placement.There was no patient injury.
Event or Problem Description
According to the reporter, during the procedure the catheter was found to be leaking from the clear tubing on the clear part near the clamp.There were two pinholes found in the silicone tubing and flushing was recommended to see the holes.As a result, the catheter was removed, and another catheter was inserted to resolve the issue.There was no leaking at the junction of the bifurcate and catheter, there was no luer adapter issue and the insertion site was treated with chloroprep prior to product placement.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The 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 red port side.Two small holes were 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 holes 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: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 8488281
• Report Number: 3009211636-2019-00078
• Device Sequence Number: 19502075
• Product Code: MSD
• UDI-Device Identifier: 10884521056657
• UDI-Public: 10884521056657
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2019

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 Model Number: 8888145039
• Device Catalogue Number: 8888145039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 03/21/2019; 06/18/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 04/10/2019; 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1