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

Catalog Number 165816

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the catheter developed a ridge upon deflation.The ridge created a delay in removal.

Manufacturer Narrative

The sample was not returned for eval, however, a picture was attached to the investigation file where a catheter can be observed showing a balloon cuff roll.The lot number is unk, therefore, the device history record could not be reviewed.There are no changes in the manufacturing process that would have contributed adversely with the reported problem.(b)(4).

• Brand Name: 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: 4349337
• MDR Text Key: 5178012
• Report Number: 1018233-2014-00343
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 165816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1