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

Model Number	8888412015
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, as the doctor performed peritoneal dialysis catheterization, the peritoneal dialysis tube was found to have leakage (dialysate) during postoperative examination.After the peritoneal fluid was flushed, leakage was found at the connection between the peritoneal dialysis tube and the titanium joint.Immediately, the peritoneal dialysis tube was cut short and replaced with the external short tube to resolve the issue.There was no blood leak and blood transfusion was not indicated.As it may cause infection to the patient, peritoneal dialysis fluid was added and left the abdomen for 3 days to prevent infection.No infection had occurred so far.The engineer stated that the leakage might be caused by the quality problem of the pipeline.It was also reported that the clamps moved to a new location after treatment.No intervention/treatment was required due to the leak and there were no noticeable damage upon visual inspection prior to use.There was no patient harm.

• Brand Name: ARGYLE
• Common Device Name: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 8712702
• Report Number: 3009211636-2019-00142
• Device Sequence Number: 1684773
• Product Code: FJS
• UDI-Device Identifier: 10884521055490
• UDI-Public: 10884521055490
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2022
• Device Model Number: 8888412015
• Device Catalogue Number: 8888412015
• Device Lot Number: 1720000084
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR