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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERIT CUSTOM KIT; CATHETER, INTRAVASCULAR, DIAGNOSTIC

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MERIT MEDICAL SYSTEMS, INC. MERIT CUSTOM KIT; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Catalog Number K12T-04870B
Device Problems Hole In Material (1293); Out-Of-Box Failure (2311); Tear, Rip or Hole in Device Packaging (2385); Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/08/2014
Event Type  malfunction  
Event Description
The user reported there is a small hole in the clear film material of the package causing a breach in the sterile barrier.This was discovered at prep and the kit was not used on pt.
 
Manufacturer Narrative
Device eval: the device is not expected to return for eval.A f/u report will be submitted when the eval has been completed.
 
Manufacturer Narrative
The device history record was reviewed and no exception documents were found.The complaint database was reviewed and no similar complaints for this lot number were found.Merit is unable to determine a root cause without the returned device.
 
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Brand Name
MERIT CUSTOM KIT
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
south jordan UT
Manufacturer Contact
jerry mcphine
1600 west merit pkwy
south jordan, UT 84095
8012084491
MDR Report Key3944072
MDR Text Key4603506
Report Number1125782-2014-00004
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K913682
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative,company representative
Reporter Occupation Not Applicable
Type of Report Initial,Followup
Report Date 04/08/2014
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 Date08/31/2016
Device Catalogue NumberK12T-04870B
Device Lot NumberT578172
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/08/2014
Initial Date FDA Received05/01/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/04/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2014
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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