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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN PD CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING
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UNKNOWN PD CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING Back to Search Results
Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Peritonitis (2252)
Event Date 06/09/2021
Event Type  Injury  
Event Description
On (b)(6) 2021, it was reported that this patient on peritoneal dialysis (pd) was hospitalized with peritonitis and may need the pd catheter removed.There were no reported allegations that the event was associated with any issues with fresenius device or product.During additional follow-up, the patient's pd nurse reported that the patient having symptoms of abdominal pain.As a result, on (b)(6) 2021, the patient was seen in the outpatient pd clinic.The patient had a pd culture obtained which yielded growth of staphylococcus epidermis.The patient was treated with vancomycin and fortaz intra-peritoneal (ip) per clinic protocol on an outpatient basis.Additionally, the nurse stated the patient had the pd catheter (not a fresenius product) removed in the hospital (not admitted, performed as an outpatient procedure).The patient is recovering and has transitioned to hemodialysis.The patient's nurse confirmed the patient did not have any fluid leaks or any issues with fresenius device or product in relation to the peritonitis event.The nurse attributed the event to patient breach in aseptic technique.(b)(4), ce00108490.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
PD CATHETER
Type of Device
CATHETER, PERITONEAL, LONG-TERM INDWELLING
Manufacturer (Section D)
UNKNOWN
MDR Report Key17536971
MDR Text Key321153370
Report NumberMW5143854
Device Sequence Number1
Product Code FJS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Patient Sequence Number1
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