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

Model Number	8888135162
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2018
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 procedure, there was a leak on the extension tube at the junction of the tube and bifurcate.This was noticed before being implanted and was not used.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.All dhr are reviewed for accuracy prior to product release.Sample consisted in one catheter used came inside a generic plastic bag.Visual evaluation of the sample reveals signs of use (residues of blood).Underwater test was performed and leaks were identified in the catheter (in the extensions tube arterial and venous) cuts were observed on tubing¿s.Manufacturing performs 100% leak testing as per procedure which would identify this issue in the catheter assembly.The reported condition has been confirmed.The physical sample involved in the reported incident was returned for evaluation.Based on the available information and the result of the dhr review that showed no deviations, it can be concluded that product was manufactured according to specifications and the device functioned as intended for an undetermined amount of time.100% devices are inspected for leaks or cuts in the extensions.The most probable root cause can be considered as misuse.The evidence provided is enough to discard the manufacturing process as a potential cause.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 m anufacturing 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, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 7237989
• Report Number: 3009211636-2018-00036
• Device Sequence Number: 1177306
• Product Code: MPB
• UDI-Device Identifier: 10884521006379
• UDI-Public: 10884521006379
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K030209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2018

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: 03/21/2020
• Device Model Number: 8888135162
• Device Catalogue Number: 8888135162
• Device Lot Number: 1508300122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1