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

Model Number 8813817009

Device Problem Difficult to Remove (1528)

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, intraoperatively, the guide wire was stuck while inserting the catheter into the patient.The guide wire did not come out of the venous ultem adapter and was tuck inside the catheter.The catheter was not repaired, there was no leak, betadine was the cleaning agent used on the device, tego was not utilized and there was no luer adapter issue.There was nothing unusual found on the device prior to use.Flushing was done without any issues noted.The lines were not reversed.The guide wire used was included in the kit.The guide wire was completely pulled together with the catheter and all pieces were accounted for.There was no excessive force used.The guide wire was intact upon removal.They had to use a fresh catheter.There was no reported patient injury.

Manufacturer Narrative

Additional information: g4, h3, h6 h3 evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted: the catheter, introducer needles, guide wire, dilators, wound dressing and sealing caps appeared intact.A functional evaluation found that was 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 and passed through 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.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,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: 9988291
• MDR Text Key: 188645337
• Report Number: 3009211636-2020-00084
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10884521004917
• UDI-Public: 10884521004917
• 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
• Report Date: 05/26/2020

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: 01/17/2022
• Device Model Number: 8813817009
• Device Catalogue Number: 8813817009
• Device Lot Number: 1704600107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Manufacturer Received: 04/09/2020
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: 05/12/2020
• Supplement Dates FDA Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR