MAUDE Adverse Event Report: CONVATEC LIMITED FLEXI-TRAK (LARGE) ANCHORING DEVICE 50PACK; ACCESSORIES, CATHETER

Model Number 37449

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Discomfort (2330); Blood Loss (2597)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction and a non-serious injury.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Additional details have been requested but not provided to date.Should additional information become available, a follow-up report will be submitted.Reported to the fda on november 22, 2016.(b)(4).

Event Description

Complaint reported, "catheter inserted, flexi-track attached, patient showered the next day, nurse finds flexi-track flaps/tabs have detached and catheter is no longer attached causing trauma for the bladder neck, urethra and discomfort for the patient.At times there will also be bleeding from trauma at catheter site." the reporter clarified that there was "no hemorrhage but blood around site caused through the trauma of the detachment" no further information was provided.

• Brand Name: FLEXI-TRAK (LARGE) ANCHORING DEVICE 50PACK
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): CONVATEC LIMITED; first avenue; deeside industrical park; deeside, flinshire CH52N U; UK CH52NU
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 6123275
• MDR Text Key: 60872882
• Report Number: 1000317571-2016-00100
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1