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

Model Number PP14SD

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problems Erosion (1750); Pressure Sores (2326)

Event Type  malfunction  

Manufacturer Narrative

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 silicone catheter.The customer reports: the silicone catheters are responsible for glans erosion wounds in the patient.Erosions on glans beside insertion point (not within urethra).All were blisters.Wound nurse notations say pressure ulcers.Charted: there were issues reported with catheters coming apart from the tubing with minimal traction.As a result our cauti rate increased.

• 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: 5901044
• MDR Text Key: 53935961
• Report Number: 9612030-2016-00396
• 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
• Report Date: 08/12/2016

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
• Initial Date Manufacturer Received: 08/12/2016
• Initial Date FDA Received: 08/24/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention