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

Model Number 8888145002

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2020

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 dialysis, a leakage was observed on the red (arterial) luer adapter.It was stated that a crack was observed on the adapter which caused the leak.It was also stated that no instrument was used to tighten and loosen the device.Betadine was the cleaning agent used, tego was not utilized.The catheter was not repaired and was removed and replaced with another catheter of the same model.There was no reported patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted: the extension tube for the blue luer adapter was cracked and broken.Pmv performed functional testing, the catheter was submerged into a water bath.The end was clamped, and a syringe was used to inject air to observe leakage.No air bubbles were present.The red adapter side was tested with acceptable results.A test guide wire was used and passed through the lumen with no occlusion.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the cracked blue luer adapter may occur when excessive force is applied during clinical application.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during dialysis, a leakage was observed on the red (arterial) luer adapter.It was stated that a crack was observed on the adapter which caused the leak.It was also stated that no instrument was used to tighten and loosen the device.There was blood loss of 3 ml and no blood transfusion was required.There was nothing unusual observed in the device prior to use.No other products was utilized with the device.Betadine was the cleaning agent used, tego was not utilized.It was stated that the patient was not responsible for any type of catheter maintenance and the cleaning agent was not switched over the life of the device.The catheter was not repaired and the faulty catheter was removed and replaced with another catheter of the same model.There was no reported patient injury.

• 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: 9716923
• MDR Text Key: 191593071
• Report Number: 3009211636-2020-00048
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 20884521014142
• UDI-Public: 20884521014142
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2021
• Device Model Number: 8888145002
• Device Catalogue Number: 8888145002
• Device Lot Number: 1617400187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1