MAUDE Adverse Event Report: UNOMEDICAL SDN BHD SILICONE 2 WAY PAED CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number 907.421.0310

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rupture (2208); Organ Dehiscence (2502)

Event Date 06/10/2016

Event Type  Injury  

Manufacturer Narrative

Expiration date: 07/2020.Manufacture date: 07/2015.Based on the available information, this event is deemed to be a serious injury.A batch record review indicate no discrepancies could be found.This issue will be monitored through the post market product monitoring review.No additional details have been provided to date.Should additional information become available, a follow-up report will be submitted.Reported to the fda on: june 30, 2016.(b)(4).

Event Description

Complaint received from a nurse reporting a surgical complication that occurred in a pediatric patient using the device.Reporter stated "catheter inserted in theatre for re-implantation of ureter.The patient had to return to theatre the following day because rupture/dehiscence of the patient's bladder." the patient underwent a laparoscopic re-implantation of ureter into bladder and "exhibited signs and symptoms which led the surgeon to believe the patient needed to return to theatre within 24 hours of the original operation." it is not known if the patient experienced urinary retention, however, the device was removed.Rupture/dehiscence of the bladder was confirmed and surgical repair was successful.Patient was discharged from the hospital ten days after the original operation.No further information was provided.

• Brand Name: SILICONE 2 WAY PAED CATHETER
• 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: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5765268
• MDR Text Key: 48652608
• Report Number: 9611710-2016-00074
• Device Sequence Number: 1
• Product Code: EZL
• 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,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2016

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 Model Number: 907.421.0310
• Device Lot Number: 8147320R001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2016
• Initial Date FDA Received: 07/01/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR