MAUDE Adverse Event Report: UNOMEDICAL SDN BHD C BNPD 08X05 SEC; CATHETER, RETENTION TYPE, BALLOON

Model Number E205-08TN

Device Problems Inflation Problem (1310); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).Evaluation conclusions are reflected.

Event Description

It was reported asymmetric inflation at the prior test before use.

• Brand Name: C BNPD 08X05 SEC
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): UNOMEDICAL SDN BHD; bakar arang ind estate; sungai petani; kedah, 08000 ; MY 08000
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5188042
• MDR Text Key: 29849779
• Report Number: 9611710-2015-31136
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K770256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2014

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: No Information
• Device Model Number: E205-08TN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2012
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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