MAUDE Adverse Event Report: UNKNOWN PERITONEAL DIALYSIS (PD); CATHETER, PERITONEAL, LONG-TERM INDWELLING

Device Problem Use of Device Problem (1670)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

A patient peritoneal dialysis (pd) catheter was surgically removed and replaced on (b)(6) 2023 as an outpatient.On (b)(6) 2023, the patient returned to the hospital due to excess bleeding around the incision (sutured).Per the peritoneal dialysis registered nurse (pdrn), the events were unrelated and not due to deficiency or malfunction of any fresenius product(s), device(s) or drug(s).File #: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL DIALYSIS (PD)
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17488089
• MDR Text Key: 320685905
• Report Number: MW5120812
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1