MAUDE Adverse Event Report: UNKNOWN PD CATHETER; CATHETER, PERITONEAL

Device Problem Obstruction of Flow (2423)

Patient Problem Unspecified Infection (1930)

Event Date 11/30/2020

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient contracted peritonitis and was put on hold from receiving pd products.The patient was provided antibiotics and the catheter was removed.Upon follow-up with the reporting nurse, it was stated there is no documentation that the patient had a true peritonitis event.The nurse stated that the patient notified the pd clinic of not being able to drain.Subsequently, the patient was hospitalized on an outpatient basis for placement of a hemodialysis (hd) catheter as the patient could not drain at all from the pd catheter (not a fresenius product).The nurse indicated there is no documentation of any cultures that would indicate a peritonitis event occurred, but it was reported the patient did have antibiotics (unknown reason or treatment details).The nurse states there are no issues with fresenius products involved with the event.Per the nurse, the patient remains on back up hemodialysis and is recovering.Based on the available information, there is no allegation or indication that a fresenius device or product issue caused or contributed to a serious patient harm or injury.Additionally, there is no objective evidence which support the patient had peritonitis.After reviewing the reported information, the patient's hospitalization was related to malfunctioning pd catheter which is not a fresenius product.The catheter used by the patient is not a fresenius device.The manufacturer of the catheter, and further product information, is unknown.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PD CATHETER
• Type of Device: CATHETER, PERITONEAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17531229
• MDR Text Key: 321141621
• Report Number: MW5138144
• Device Sequence Number: 1
• Product Code: GBW
• 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: 12/30/2020

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1