MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	8830415003
Medical Device Problem Codes	Occlusion Within Device (1423); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2017
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 insertion, the guide wire would not go through the lumen because it was partially blocked.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: a device history review was performed to the reported lot.No discrepancies that may have contributed to a complaint of this nature were found.All dhrs are reviewed for accuracy prior to product release.No changes related to the reported condition were found within six months prior to lots manufacturing date.The physical sample involved in the reported incident was not returned for evaluation.Two photos were provided by the customer.Visual evaluations of these photos were performed; the first picture showed a dual catheter, an introducer needle, two dilators and guide wire inside of one pouch, in this image was not possible observed any defect.In second image it was appreciate in a corner the ends of the guide wire near the venous adapter inside the pouch, in this image was not possible observed any defect.The both photos it showed signs of use (remains of blood); however with the pictures provided it was not possible to confirm the occlusion in the catheter.This defect was not confirmed; the product sample was not returned to the manufacturing site for review.During visual inspection of the photo it could not be appreciated any occlusion.Based on the available information the most probable root cause is considered as customer perception.None has been confirmed as manufacturing related issues.No triggers or trends were identified.No further actions are required.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% visual inspection, and visual acceptance sampling are performed in the plant) are in place to prevent nonconforming product from leaving the manufacturing operations.No additional actions are required.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,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 7213580
• Report Number: 3009211636-2018-00026
• Device Sequence Number: 1022966
• Product Code: FOZ
• UDI-Device Identifier: 20884521005171
• UDI-Public: 20884521005171
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

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: 06/26/2021
• Device Model Number: 8830415003
• Device Catalogue Number: 8830415003
• Device Lot Number: 1620800062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 01/23/2018
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 59