MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PERMCATH; CATHETER, SUBCLAVIAN

Model Number 8817748001

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during use, there was a leakage at the bifurcate of the catheter.There was no patient injury.

Manufacturer Narrative

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

Event Description

According to the reporter, during the patient's daily dialysis, there was a leakage at the bifurcate of the catheter.The catheter was replaced with a new one.It was reported that none of the cleaning agents used were mixed or switched over the life of the catheter.In addition to that, the cleaning agents used were allowed to dry thoroughly prior to applying ointments and dressing the area.There was no patient injury.

• Brand Name: PERMCATH
• Type of Device: CATHETER, SUBCLAVIAN
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: jacqueline st. pierre ; 15 hampshire street; mansfield, MA 02048 ; 5084524938
• MDR Report Key: 7479299
• MDR Text Key: 107197833
• Report Number: 3009211636-2018-00136
• Device Sequence Number: 1
• Product Code: LFJ
• UDI-Device Identifier: 20884521009865
• UDI-Public: 20884521009865
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K871942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2021
• Device Model Number: 8817748001
• Device Catalogue Number: 8817748001
• Device Lot Number: 1632100171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2018
• Date Device Manufactured: 11/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR