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

Model Number PERITONEAL CATHETER

Device Problem Break (1069)

Patient Problems Fever (1858); Vomiting (2144); Peritonitis (2252); Radiation Exposure, Unintended (3164); No Code Available (3191)

Event Date 12/01/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: exit-site infection and acute peritonitis due to peritoneal dialysis catheter rupture: masa knehtl, 2015, clinic of internal medicine, department of nephrology and department of dialysis.Source: may 2015 ¿ vol.35, no.3.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature article, the patient started with continuous ambulatory peritoneal dialysis (capd) in 2007 due to hypertension as a cause of end-stage renal disease (esrd), and after 6 months, was changed to apd.Exit-site care was performed routinely with soap, saline, and a product for skin disinfection, occasionally with mupirocin.The patient had an episode of acute peritonitis with difteroides in 2010.Two years later the patient was admitted and reported 2 days of vomiting, abdominal pain and a fever of 37.8c.In the 6 months before admission, intermittent problems with negative ultrafiltration were noted, and two months before admission she had a hernioplasty.The patient also reported falling on the stairs on her back a few weeks before her admission.On initial evaluation after that event, she had a temperature of 37.2°c, the abdominal examination revealed generalized tenderness, the external part of the pd catheter appeared normal, with no breaks or kinks, but there were signs of esi with a green discharge.Patient was treated with ceftazidime and cefazolin, but ceftazidime was discontinued when coagulase-negative staphylococcus aureus grew in hemoculture and from the exit-site culture as well.The patient responded well, but the drainage was slow, the volumes were gradually decreasing to zero, and fluid leakage was noted.After patients admission, an abdominal x-ray was performed and it was confirmed that the catheter tip was well positioned but there was a disruption of the device noted.Removal of the device revealed it was split into two parts.All patient symptoms were related to the device use and procedure.No other products were utilized with the device (pd catheter).The patient discontinued apd and hemodialysis was initiated.

• Brand Name: PERITONEAL CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 8671727
• MDR Text Key: 147091650
• Report Number: 3009211636-2019-00138
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: SI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PERITONEAL CATHETER
• Device Catalogue Number: PERITONEAL CATHETER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 77