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  Injury  

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

Please see correction in section originally reported as malfunction and has been corrected to serious injury.

Manufacturer Narrative

There were no physical samples or pictures submitted with this complaint report.The device history record (dhr) file was reviewed indicating that product was released meeting all quality standard requirements.The product was manufactured on 06/06/2016.The exact root cause of the reported condition stated by the customer could not be determined due to no physical sample being received for evaluation.Based on previous reports, a formal investigation with a corrective and preventive action (capa) was opened.As a result of this investigation the root cause was determined to be operator fatigue.The connector has 5 steps in which the manufacturing requirement is to assemble until the 4th ring; it was shown in the investigation that the operator did not always assemble until the 4th ring.Studies show that the less rings assembled the less pull test it has.The procedure was updated to change the assembly specification.The lab was modified for the pull test specification for silver coating, latex, silicone and temperature sensing.A pull test was added as a quality release inspection for silver coating, silicone, latex and temperature sensing catheters.As part of the capa, there will be a replacement of the manual assembly to a semi-automated fixture.This complaint will be recorded 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: 5903213
• MDR Text Key: 54071867
• Report Number: 9612030-2016-00403
• Device Sequence Number: 1
• Product Code: GBL
• 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,Followup
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• 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: 12/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention