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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL RICHMOND SUTURE KIT; CUSTOM KIT
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MERIT MEDICAL RICHMOND SUTURE KIT; CUSTOM KIT Back to Search Results
Catalog Number K12T-08032
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 03/07/2018
Event Type  malfunction  
Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleged the scissors are puncturing through the sterile barrier.
 
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 no exception documents were found.Corrective actions are in process.Corrections were made after the investigation identified the lot received was different than the lot initially reported.
 
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Brand Name
SUTURE KIT
Type of Device
CUSTOM KIT
Manufacturer (Section D)
MERIT MEDICAL RICHMOND
12701 n kingston ave
chester VA 23836
MDR Report Key7385058
MDR Text Key103955014
Report Number1125782-2018-00011
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 health professional,user faci
Type of Report Initial,Followup
Report Date 03/07/2018
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 Date12/31/2020
Device Catalogue NumberK12T-08032
Device Lot NumberT1271660
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/05/2018
Initial Date FDA Received03/30/2018
Supplement Dates Manufacturer Received06/18/2018
Supplement Dates FDA Received06/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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