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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO MERIT MINI ACCESS KIT
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MERIT MEDICAL SYSTEMS MEXICO MERIT MINI ACCESS KIT Back to Search Results
Model Number 00884450012635
Medical Device Problem Codes Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 01/20/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event or Problem Description
The account alleged that the catheter fractured within the patient.The detached portion was retrieved with a vascular snare device without any further complications.
 
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.
 
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Brand Name
MERIT MINI ACCESS KIT
Common Device Name
ACCESS KIT
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS MEXICO
8830 siempre viva rd #100
san diego, ca
MDR Report Key9712689
Report Number3011642792-2020-00003
Device Sequence Number3171867
Product Code DRE
UDI-Device Identifier00884450012635
UDI-Public00884450012635
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K031691
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 01/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number00884450012635
Device Catalogue NumberS-MAK401N/C
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/20/2020
Supplement Date Received by Manufacturer07/22/2020
Initial Report FDA Received Date02/14/2020
Supplement Report FDA Received Date07/28/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Life Threatening; Required Intervention;
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