MAUDE Adverse Event Report: UNOMEDICAL SDN BHD SILICONIZED 2-WAY, HARD VALVE, CH08; CATHETER, RETENTION TYPE, BALLOON

Model Number MM53120805

Device Problems Partial Blockage (1065); Deflation Problem (1149)

Patient Problems Tissue Damage (2104); Impaired Healing (2378); Hematuria (2558)

Event Date 11/03/2011

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

Complainant reported "this little boy underwent the gastrointestinal surgery on (b)(6) 2011.At operating room he was initially inserted 2-way foley-8 fr., then the doctor determined to change to the specification 10 fr.At this moment, it failed to deflate the balloon either by withdrawing 2 c.C.Of the distilled water or by cutting.Foley could not be detected under the ultrasound over the urinary bladder so the doctor pulled off the foley directly.The little boy has hematuria and is admitted at the icu now.".

• Brand Name: SILICONIZED 2-WAY, HARD VALVE, CH08
• 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; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5290095
• MDR Text Key: 33299528
• Report Number: 9611710-2015-40046
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K770256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/06/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Model Number: MM53120805
• Device Lot Number: 403795R001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2011
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2015
• Initial Date FDA Received: 12/11/2015
• 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
• Patient Outcome(s): Required Intervention