MAUDE Adverse Event Report: COVIDIEN URETHRAL CATHETER INSERTION TRAY

Model Number 75030

Device Problem Bent (1059)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Please see the below for the investigation findings: a review of the device history record could not be conducted because a lot number was not provided.Manufacturing records are routinely reviewed prior to the release of product to ensure process and product compliance.Because a sample was not returned, we were unable to perform a thorough follow up investigation to include functional and visual evaluations to confirm the defect and root cause analysis.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.The exact root cause of the reported condition stated by the customer could not be determined for this report; however this failure could occur if the product is not packaged correctly.As a corrective action, procedures were reviewed and include visual aids that explain to the operator the correct way to make an acceptable assembly and packaging.The process is running according to product specifications meeting quality acceptance criteria.Production personnel were notified about the reported issue.If additional information is obtained, or the sample is returned, this file will be re-opened for further investigation.This complaint will also be used for qa tracking and trending purposes.

Event Description

It was reported to covidien on (b)(6) /2014 that a customer had an issue with a catheter.The customer reports that 2 years ago her son, who is paralyzed, experienced trauma to his penis as a result of a bent catheter and ended up in the hospital for several days.The curved catheter resulted in ripped lining of his penis.The customer stated that because it was so long ago she could not remember if he was prescribed any antibiotics.The customer further stated that the hospital put a leave in catheter (believed to be a foley for 1-2 weeks) not intermittent.There were no stitches involved.

Manufacturer Narrative

An investigation is currently underway, upon completion the results will be forwarded.

• Brand Name: URETHRAL CATHETER INSERTION TRAY
• 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 9217 3; MX 92173
• Manufacturer Contact: janice nevius ; 15 hampshire street; mansfield, MA 02048 ; 5082616283
• MDR Report Key: 4286208
• MDR Text Key: 13030137
• Report Number: 9612030-2014-00073
• Device Sequence Number: 1
• Product Code: FCM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 75030
• Device Catalogue Number: 75030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2015
• 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): Hospitalization