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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL SDN BHD 2-WAY, HARD VALVE, STANDARD TIP, 30CC , CH14; CATHETER, RETENTION TYPE, BALLOON
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UNOMEDICAL SDN BHD 2-WAY, HARD VALVE, STANDARD TIP, 30CC , CH14; CATHETER, RETENTION TYPE, BALLOON Back to Search Results
Model Number MM51181430
Device Problem Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Date 07/08/2014
Event Type  malfunction  
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.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
 
Event Description
It was reported the catheters are deformed.
 
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Brand Name
2-WAY, HARD VALVE, STANDARD TIP, 30CC , CH14
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 Key5204296
MDR Text Key30492230
Report Number9611710-2015-31208
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K944007
Number of Events Reported1
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
Date FDA Received11/05/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date03/01/2019
Device Model NumberMM51181430
Device Lot Number545505R001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received02/27/2014
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 Number1
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