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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL RICHMOND MERIT CUSTOM KIT
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MERIT MEDICAL RICHMOND MERIT CUSTOM KIT Back to Search Results
Catalog Number K12T-06901G
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 03/16/2018
Event Type  malfunction  
Manufacturer Narrative
The suspect device has returned for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleged that a hole in the drape and the header bag was found while preparing the device for a procedure.
 
Manufacturer Narrative
One device was returned for evaluation.The device was examined visually and the complaint was confirmed.The root cause is attributed to the packaging process.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and one exception document was found.Corrective actions are in process.
 
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Brand Name
MERIT CUSTOM KIT
Type of Device
CUSTOM KIT
Manufacturer (Section D)
MERIT MEDICAL RICHMOND
12701 n kingston ave
chester VA 23836
MDR Report Key7441956
MDR Text Key105910370
Report Number1125782-2018-00022
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/09/2018
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 No Information
Device Expiration Date09/30/2019
Device Catalogue NumberK12T-06901G
Device Lot NumberT1268330
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/09/2018
Initial Date FDA Received04/18/2018
Supplement Dates Manufacturer Received07/13/2018
Supplement Dates FDA Received07/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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