MAUDE Adverse Event Report: UNOMEDICAL LTD. CATHY-CLOSED S.CH14 45CM/78; CATHETER, NASAL, OXYGEN

Model Number 36014182

Device Problem Inflation Problem (1310)

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

Event Date 04/30/2014

Event Type  malfunction  

Event Description

It was reported "inflation of catheter sleeve (making it difficult to manipulate the catheter due to the air pressure); moisture build-up inside the sleeve".Note: this reported issue occurred on five separate cases.

Manufacturer Narrative

Based on available information, this event is deemed a reportable malfunction.It was further reported that the "hospital is concerned with infection".Additional event info was provided via email on (b)(6) 2014 informing that they replaced the device due to the continued issues with sleeve inflation and moisture build-up.No info was provided or reported that any infections had occurred to pt(s); they further informed that they cannot determine exact number of pt(s) involved and the product was used in the surgical intensive care unit.They went on the inform that it is unk how long the product was in use prior to the event occurring.Please note: issue occurred on five (5) separate cases.A separate 3500a form has been completed for the other (4) cases under pt identifier(s):# (b)(6).Mfr report(s):# 3007966929-2014-00017, 3007966929-2014-00019, 3007966929-2014-00023 and 3007966929-2014-00019, 3007966929-2014-00023 and 3007966929-2014-00025 respectively.(report 3 of 5) no additional pt/ event details have been provided to date.Should additional info become available a follow-up report will be submitted.Note: the actual date of event is unk, so the date used was the date convatec became aware.

• Brand Name: CATHY-CLOSED S.CH14 45CM/78
• Type of Device: CATHETER, NASAL, OXYGEN
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol; dzerzhinsk district minsk region 2227 50; BO 222750
• Manufacturer Contact: matthew walenciak, director ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3908254
• MDR Text Key: 18298594
• Report Number: 3007966929-2014-00021
• Device Sequence Number: 1
• Product Code: BZB
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/30/2014

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 Expiration Date: 12/01/2013
• Device Model Number: 36014182
• Device Catalogue Number: 36014182
• Device Lot Number: 635431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2014
• Initial Date FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• 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