MAUDE Adverse Event Report: UNOMEDICAL SDN BHD PEDIATRIC FOLEY CATHETERS; CATHETER, RETENTION TYPE, BALLOON

Model Number 53121005

Device Problem Deflation Problem (1149)

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

Event Type  malfunction  

Event Description

It was reported that only one milliliter was aspiration from the balloon on a foley catheter.The urologist cut the balloon port allowing it to drain then the catheter was removed after two days.

Manufacturer Narrative

Based on the available info, this event is deemed to be a reportable malfunction.No add'l pt/event details have been provided to date.Should add'l info become available, a follow up report will be submitted.

• Brand Name: PEDIATRIC FOLEY CATHETERS
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): UNOMEDICAL SDN BHD; bakar arang industrial estate; sungai petani, kedah 08000 ; MY 08000
• Manufacturer Contact: matthew walenciak, interim associ ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4349695
• MDR Text Key: 17218856
• Report Number: 9611710-2014-00388
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K954752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Model Number: 53121005
• Device Lot Number: 404533R001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2014
• Initial Date FDA Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• 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 Outcome(s): Required Intervention
• Patient Age: 10 YR