MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER

Catalog Number 165814

Device Problem Physical Resistance (2578)

Patient Problem Pain (1994)

Event Date 07/07/2014

Event Type  malfunction  

Event Description

It was reported that when catheter was removed the bubble rolled back on itself and formed a rim or mushroom which caused resistance and pain upon removal.Per add'l info received, the catheter was placed on (b)(6) 2014 and was indwelling for approximately 20 hours.The catheter was placed transurethrally because the pt was critically ill on a ventilator.A 10cc of sterile water was used to inflate the catheter.Regular catheter irrigation ws not performed, nor were any sutures placed to anchor the catheter.The pt was not disoriented or pulling on the catheter, nor was traction applied; the catheter was not clamped off at any time.No add'l tests were performed and the pt was transferred out of icu on (b)(6) 2014.The catheter balloon was deflated with aspiration and was removed by pulling it out, resistance was felt upon removal.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report wll be filed.

• Brand Name: BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD; nogales, sonora ; MX
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD; km 7 carretera internacional; nogales, sonora 8562 1; MX 85621
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4088213
• MDR Text Key: 4757393
• Report Number: 1018233-2014-00191
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 165814
• Device Lot Number: NGXG1728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 66