MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. ARGYLE; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number 8888412015

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during use, a rupture occurred at the connection between the peritoneal tube and the external joint.It was reported that there was a leak at the junction of the extension tube and bifurcate which is also the catheter's shaft.The doctor had cut-off the broken part considering that the patient is still using the abdominal tube.Intervention was done by letting the rest of the catheter part be used normally, avoiding the damage caused to the patient by tube drawing and re-drawing.It was stated that this treatment method is also a common treatment method at present.The catheter was being cleaned without using of detergent and ointment but with usage of sterile gauzes.The patient is also responsible for the catheter maintenance like cleaning, dressing changes, etc.It was stated that there was no patient injury.

• Brand Name: ARGYLE
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• 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: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 8304756
• MDR Text Key: 134992822
• Report Number: 3009211636-2019-00021
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 10884521055490
• UDI-Public: 10884521055490
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K862046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888412015
• Device Catalogue Number: 8888412015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2019
• 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