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

Model Number 8888111132

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, on post op visit, the insertion site and exit sites were noted to have erythema and purulent drainage.The patient was started on po bactrim for infection and had to return to surgery for catheter removal.It was also reported that the insertion site was treated with chloraprep and loban prior to the product placement.The product was implanted but was then removed after more than a week.

• Brand Name: PERITONEAL
• 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: jacqueline st. pierre ; 15 hampshire street; mansfield, MA 02048 ; 5084524938
• MDR Report Key: 7419722
• MDR Text Key: 105110012
• Report Number: 3009211636-2018-00116
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 10884521196087
• UDI-Public: 10884521196087
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888111132
• Device Catalogue Number: 8888111132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/10/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR