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

Model Number	8817278007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	10/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the nurse stated that the patient went to the renal unit, conscious, oriented, and when the product was being used at the hospital, there was leakage of peritoneal fluid by catheter.Physical examination was performed and peritoneal fluid leakage was evidenced at the level of the catheter and titanium adapter junction, urgent titanium line and adapter change was performed, then permanent peritoneal fluid with dianeal x 2.5% x 2000 ml for a period of three hours and subsequently drained turbid liquid, on the order of the nephrologist, fluid culture, gram, antibiogram, cell count, started amikacin 100 mg ip (intraperitoneal injection) every 24 hours and cefazoline 1 gr every 24 hours ip performed.The outcome was that the patient presented a klebsiella pneumoniae peritonitis recio, complete scheme of antibiotic cefepime performed and peritonitis resolved.No hospitalization required.The catheter was not repaired, there was a leak from the luer adapter, no crack observed in the luer adapter, tego was not utilized and there was no luer adapter issue.

• 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 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 12975609
• Report Number: 3009211636-2021-00356
• Device Sequence Number: 20012556
• Product Code: FJS
• UDI-Device Identifier: 10884521004269
• UDI-Public: 10884521004269
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K180485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2021
• Device Model Number: 8817278007
• Device Catalogue Number: 8817278007
• Device Lot Number: 1619500126
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 12/10/2021
• Date Device Manufactured: 07/15/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female