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

Model Number 8813817009

Device Problem Obstruction of Flow (2423)

Patient Problem No Patient Involvement (2645)

Event Date 09/13/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, prior to use, it was stated that the arterial line was blocked.It was also stated that the catheter was not repaired, there was no leak, iodine solution was the cleaning agent used, tego was not utilized amd there was no luer adapter issue.There was no reported patient involvement.

Manufacturer Narrative

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

Event Description

According to the reporter, prior to use, it was stated that the arterial line was blocked.The flushing was performed prior to use and was successful.Nothing unusual was observed prior to use.It was also stated that the catheter was not repaired, there was no leak, iodine solution was the cleaning agent used, tego was not utilized and there was no luer adapter issue.Another catheter was used to resolve the issue.There was no reported patient involvement.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection noted that the guide wire wouldn't pass through the hub in the venous lumen.An engineering evaluation of the returned product noted found that one of the lumens was smaller than the other, which prevented the guide wire from passing through it.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, a manufacturing fault was identified during product analysis.The root cause of the observed condition was determined to be a result of a manufacturing activity.Occlusion of the venous lumen was caused by an excess of solvent during the manufacturing process.Improvements have been initiated to mitigate this 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: 8416136
• MDR Text Key: 138764020
• Report Number: 3009211636-2019-00061
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 20884521004914
• UDI-Public: 20884521004914
• 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: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2021
• Device Model Number: 8813817009
• Device Catalogue Number: 8813817009
• Device Lot Number: 1624600122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1