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

Model Number PP14SD

Device Problems Material Separation (1562); Device Operates Differently Than Expected (2913)

Patient Problems Erosion (1750); Swelling (2091); Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

Submit date: 08/24/2016.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.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.

Manufacturer Narrative

Correction change from malfunction to add serious injury.

Manufacturer Narrative

Submit date: 11/09/2016.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: 5901108
• MDR Text Key: 54043000
• Report Number: 9612030-2016-00397
• Device Sequence Number: 1
• Product Code: MSD
• 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

• Date FDA Received: 08/24/2016
• 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
• Date Manufacturer Received: 11/09/2016
• 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