MAUDE Adverse Event Report: COVIDIEN LP ARGYLE PERITONEAL DIALYSIS CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number 8811313010

Patient Problem Foreign Body In Patient (2687)

Event Date 10/10/2023

Event Type  malfunction  

Event Description

Writer received a call at 0900 from home therapies nurse at patient¿s dialysis unit.Rn (registered nurse) said patient had some leaking from her pd (peritoneal dialysis) exit site three days prior, so they rested catheter over the weekend.When she came in and they connected her, fluid started squirting out from the small holes in the catheter (that is supposed to sit in patient's pelvis), and the catheter was about 3/4ths out.Nurse also said he felt the superficial cuff during initial visit, but could not three days later.Patient was brought into clinic at 1130 and seen by surgeon.Surgeon was able to pull the pd catheter out without resistance and both cuffs were not attached to the catheter.Surgeon saw both cuffs while placing catheter three weeks prior, and does not understand how both came off of the catheter.Patient now does not have a means of dialysis.Result was an unintentionally retained foreign object(s).

• Brand Name: ARGYLE PERITONEAL DIALYSIS CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 17984372
• MDR Text Key: 326250205
• Report Number: 17984372
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8811313010
• Device Lot Number: 2234800172
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25185 DA
• Patient Sex: Male