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

Model Number DIALYSIS UNKNOWN

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the line fell out following insertion (within seven to eight).It was stated that cuff preparation was still being performed, no new inserted and sutures are staying in for up to six to eight weeks post line insertion.The catheter was not repaired, there was no luer adapter issue and a new line was inserted.There was no reported patient injury.

• Brand Name: DIALYSIS UNKNOWN
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 12725555
• MDR Text Key: 279259477
• Report Number: 3009211636-2021-00303
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIALYSIS UNKNOWN
• Device Catalogue Number: DIALYSIS UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2021
• 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