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

Model Number 8830415001

Device Problems Difficult to Remove (1528); Defective Component (2292); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, intraoperatively, the guide wire that came with the kit was stuck in the catheter and did come out of the venous line (blue color) of the catheter. It was reported that the catheter has some blockage near the hub and because the guide wire was stuck inside the catheter. It was stated the flushing was done using normal saline and no abnormality was found. It was also stated that occlusion due to thrombosis was ruled out as the catheter was not reused. The catheter was not repaired, chlorhexidine gluconate was the cleaning agent used, tego was not utilized, there was no luer adapter issue and the insertion site was not treated prior to product placement. There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one case of representative samples of the device. The visual inspection of the devi ce noted the catheter kit appeared intact. Pmv performed functional testing, the catheters were submerged into a water bath. The ends were clamped, and a syringe was used to inject air to observe leakage. No air bubbles were present. Both extensions were tested with acceptable results. The guide wire was inserted into the lumen and passed through without 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. Analysis concluded there were no assembly component related failures. If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAHURKAR
• Type of Device: 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: 8407609
• MDR Text Key: 138368861
• Report Number: 3009211636-2019-00056
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K943349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/14/2021
• Device Model Number: 8830415001
• Device Catalogue Number: 8830415001
• Device Lot Number: 1701100176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No