MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	8888145039
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2016
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, the peel-away sheath (dilator) of the device was found to be bent at the tip as it passes through the skin's entrance hole intraoperatively.It was also stated that there was a crack observed in the luer adapter.It was noted that the catheter was not repaired.There was no patient injury.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8872470
• Report Number: 2647580-2019-04050
• Device Sequence Number: 16676355
• Product Code: MSD
• UDI-Device Identifier: 10884521056657
• UDI-Public: 10884521056657
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2019

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
• Device Lot Number: 1517400096
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR