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

Model Number 8888135191

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during a crrt (continuous renal replacement therapy) treatment, the red luer adapter was completely detached (prolapsed) from the silicone extension tube.There was nothing unusual observed with the device prior to use.It was stated that catheter was repaired after sterilizing the joint and then it was placed into the epitaxial tube.It was said that the connector for the extracorporeal circulation circuit was used to tighten the adapter.It was reported that the product had not been previously repaired and the repair which was done on the device had resolved the issue.It was also mentioned that a hemofiltration machine was being utilized and was connected through the extracorporeal circuit.There was no leak, iodophor was the cleaning agent used and tego was not utilized.There was no blood loss and blood transfusion was not required.There was no reported patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.The visual inspection of the returned photo noted: the image depicts the catheter being used during a surgical procedure.The red luer adapter is disengaged from the extension tube.There is fluid in the extension tubes.The red luer adapter extension tube is clamped shut.The blue luer adapter extension tube clamp is unlocked.Without the physical device functional evaluation is precluded.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, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 9810799
• MDR Text Key: 194372968
• Report Number: 3009211636-2020-00063
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006447
• UDI-Public: 10884521006447
• Combination Product (y/n): N
• PMA/PMN Number: K030209
• 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: 03/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2024
• Device Model Number: 8888135191
• Device Catalogue Number: 8888135191
• Device Lot Number: 1902800147
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/10/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR