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

Model Number	8888145017
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: a device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.In addition, all dhrs are reviewed for accuracy prior to product release.The physical sample involved in the reported incident was not returned for evaluation.Two photos were provided by the customer.The picture showed a catheter inside the patient with blood leaking from the venous extension.As per the instructions for use (ifu), the customer must perform a visual inspection before using the device.The ifu states that clamping the catheter repeatedly in the same spot could weaken the tubing and to exercise caution when using sharp instruments near the catheter because the catheter tubing can tear when subjected to excessive force or rough edges.The reported condition was confirmed.Based on pictures provided by the customer, it can be concluded that the most probable root cause can be considered as damaged during use.No trends or triggers have been found.No action is deemed necessary at this time.It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing operations.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, after dialysis had been completed the customer noticed the device had a leak in the middle of the silicone extension tube.The catheter was replaced and there was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: a device history review revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhr are reviewed for accuracy prior to product release.The physical sample involved in the reported incident was not returned for evaluation.Two photos were provided by the customer.Visual evaluation of the photo was performed; the picture showed a catheter inside the patient with apparently a leak of the blood in the venous extension, therefore the complaint was confirmed.The physical sample involved in the reported incident was not returned for evaluation.Based on pictures provided by customer, it can be concluded that the device functioned as intended for an undetermined amount of time.No trends or triggers have been found.No action is deemed necessary at this time.It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing operations.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7291884
• Report Number: 3009211636-2018-00059
• Device Sequence Number: 1110097
• Product Code: MSD
• UDI-Device Identifier: 10884521013193
• UDI-Public: 10884521013193
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 07/08/2021
• Device Model Number: 8888145017
• Device Catalogue Number: 8888145017
• Device Lot Number: 1621800216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 07/16/2018; 08/08/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 08/06/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR