MAUDE Adverse Event Report: COVIDIEN PRECISION PRM 14FR CATH SECURE; CATHETER

Model Number PP14SD

Device Problem Insufficient Information (3190)

Patient Problem Erosion (1750)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 08/25/2016.An investigation is currently under way.Upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a catheter.The customer reports: the silicone catheters are responsible for glans erosion wounds in the patient.

Manufacturer Narrative

Correction change from malfunction to add serious injury.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.There were no samples received for evaluation.Because a sample was not available for evaluation, a root cause analysis could not be conducted to determine the root cause of this reported issue.If samples are received at a later date, this complaint will be re-opened and the investigation continued.A formal corrective and preventative action was opened for this reported issue.This complaint will be used for tracking and trending purposes.

• Brand Name: PRECISION PRM 14FR CATH SECURE
• Type of Device: CATHETER
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125; cuidad industrial; tijuana ; MX
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5903301
• MDR Text Key: 54041976
• Report Number: 9612030-2016-00407
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2016

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: Other
• Device Model Number: PP14SD
• Device Catalogue Number: PP14SD
• Device Lot Number: 615256364
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2016
• Initial Date FDA Received: 08/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/25/2016; 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention