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

Model Number	8888345637
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2018
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 retraction of the catheter, the doctor experienced difficulty to remove the guidewire after insertion of the catheter.The doctor eventually had to remove the catheter together with the guidewire.Upon checking the guidewire, it was found to be broken and split into three (3) parts.The coiled portion was intact.A new catheter was inserted to the patient.There was no reported patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
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.All dhr are reviewed for accuracy prior to product release.One guide wire was returned with it¿s original package of the acute triple product.Visual inspection was performed and it revealed that the guide wire was stretched, broken and kinked on different points.Dimensional testing was performed.The measure of the guide wire was within specifications and the equipment was calibrated.Based on the information, no dimensional defect in the guide wire was found.The reported condition was not confirmed.The physical sample involved in the reported incident was returned for evaluation and passed the dimensional test.Based on the available information could not be attributing to manufacturing process.The most probable root cause can be considered as costumer misuse.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.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 7369973
• Report Number: 3009211636-2018-00089
• Device Sequence Number: 592334
• Product Code: NIE
• UDI-Device Identifier: 10884521006829
• UDI-Public: 10884521006829
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K020089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2018

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: 10/05/2021
• Device Model Number: 8888345637
• Device Catalogue Number: 8888345637
• Device Lot Number: 1630900090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 04/12/2018; 04/25/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 04/24/2018; 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1