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

Model Number 8830416003

Device Problem Material Puncture/Hole (1504)

Patient Problem No Code Available (3191)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

Materials manager of the hospital - (b)(6.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the catheter was placed and an x-ray confirmed the placement.Continuous renal replacement therapy (crrt) was started with no complications.The pulse oximeter started not to be able to pick up and the blood pressure (bp) started decreasing.When two nurses did full assessment, it was noted that there was blood outside of the extension tube of the blue (venous) tubing and a small hole was found in the extension tube next to the blue luer adapter upon closer inspection.The blood was only noticeable on the external catheter extension tubing when touched and it was a very minimal amount of blood.The catheter was not repaired and there was no luer adapter issue.Crrt was stopped immediately and the physician was called.The patient continued to get worse and a code was called.Catheter was removed when the patient's condition was stabilized.

Manufacturer Narrative

New information has been received.The event has been updated with the following information: initial reporter: (b)(6).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: 10270710
• MDR Text Key: 198711576
• Report Number: 3009211636-2020-00135
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10884521005228
• UDI-Public: 10884521005228
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8830416003
• Device Catalogue Number: 8830416003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other