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

Model Number 8888145001

Device Problems Material Puncture/Hole (1504); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, when the package was opened before surgery, it was found that the device¿s silicone extension tube had holes and foreign bodies.It was also stated that when the tubing was flushed, there was a leak in the silicone extension tube (between the junction of the extension tube and bifurcate) but the quantity of leak could not be provided.The catheter was not repaired, there was no luer adapter issue, and there was no tego utilized.In order to resolve the issue, the product was replaced with a new tube with the same model.There was no patient involvement.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.A visual inspection of the returned photos noted: the is a red circle drawn around the extension tube of the blue port.The second photo depicts two red circles drawn around the extension tube of the red port.Post market vigilance (pmv) led an evaluation of one device.Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAHURKAR
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 8508913
• MDR Text Key: 141754738
• Report Number: 3009211636-2019-00084
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 20884521014081
• UDI-Public: 20884521014081
• Combination Product (y/n): N
• PMA/PMN Number: K111372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2022
• Device Model Number: 8888145001
• Device Catalogue Number: 8888145001
• Device Lot Number: 1722100148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1