MAUDE Adverse Event Report: UNOMEDICAL LTD. CATHY-CLOSED S.CH12 45CM/78; CATHETER, NASAL, OXYGEN

Model Number 36011182

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 the available information, this event is deemed a reportable malfunction.It was further reported the "hospital is concerned with infection." additional event information was provided via email on (b)(4) 2014 informing that they replaced the device due to the continued issues with sleeve inflation and moisture build-up.No information was provided or reported that any infections had occurred to patient(s); they further informed that they cannot determine exact number of patient(s) involved and the product was used in the surgical intensive care unit.They went on to inform that it is unknown how long the product was in use prior to the event occurring.Issues occurred on five (5) separate cases.A separate 3500a form has been completed for the other (4) cases under patient identifier(s) (b)(4).Mfr reports #: 3007966929-2014-00017, 00019, 00021 and 00023 respectively.(report 5 of 5) no additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Note: the actual date of event is unknown, so the date used was the date convatec became aware.

• Brand Name: CATHY-CLOSED S.CH12 45CM/78
• Type of Device: CATHETER, NASAL, OXYGEN
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol dzerzhinsk district, minsk region; minskaya voblasts 2227 50; BO 222750
• Manufacturer Contact: matthew walenciak, int. ass. dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3908201
• MDR Text Key: 4583681
• Report Number: 3007966929-2014-00025
• 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: 36011182
• Device Catalogue Number: 36011182
• Device Lot Number: 635427
• 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