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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS ACCESSPLUS; HEMOSTASIS VALVE
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MERIT MEDICAL SYSTEMS ACCESSPLUS; HEMOSTASIS VALVE Back to Search Results
Catalog Number MAP152/CNB
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/22/2020
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 alleges a packaging defect was identified during preparations for a procedure.The device was not use.No patient contact or injury to report.
 
Manufacturer Narrative
The suspect device was not returned for device evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.
 
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Brand Name
ACCESSPLUS
Type of Device
HEMOSTASIS VALVE
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS
parkmore business park west
ballybrit, galway
EI 
MDR Report Key10423557
MDR Text Key204256378
Report Number9616662-2020-00010
Device Sequence Number1
Product Code DTL
UDI-Device Identifier00884450007204
UDI-Public884450007204
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,foreig
Type of Report Initial,Followup
Report Date 07/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2022
Device Catalogue NumberMAP152/CNB
Device Lot NumberK1745568
Was Device Available for Evaluation? No
Date Manufacturer Received09/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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