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

Model Number UNKNOWN DIALYSIS

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during dialysis, the catheter slipped out and it was noted that there was no cuff.It was reported the catheter was disposed from the hospital but there was no trace of the lot and code.It was reported there was no patient injury.

• 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: 7793822
• MDR Text Key: 117574461
• Report Number: 3009211636-2018-00281
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN DIALYSIS
• Device Catalogue Number: UNKNOWN DIALYSIS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/17/2018
• 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