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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. MANIFOLD; MERIT CUSTOM MANIFOLD
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MERIT MEDICAL SYSTEMS INC. MANIFOLD; MERIT CUSTOM MANIFOLD Back to Search Results
Catalog Number 503HN-R/CN
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2020
Event Type  malfunction  
Manufacturer Narrative
The suspect device has been returned for evaluation.The device was examined visually.The unit was submitted for bubble testing per stp0171.The unit failed this testing.The complaint is confirmed.The root cause is attributed to rough or improper handling after the package was sealed.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.
 
Event Description
The account alleges that during preparations for a procedure, a hole in the clear film causing a breach was identified.
 
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Brand Name
MANIFOLD
Type of Device
MERIT CUSTOM MANIFOLD
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC.
1600 merit parkway
south jordan UT 84095
MDR Report Key11338090
MDR Text Key232196521
Report Number1721504-2021-00007
Device Sequence Number1
Product Code DQO
UDI-Device Identifier00884450018965
UDI-Public884450018965
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
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/12/2023
Device Catalogue Number503HN-R/CN
Device Lot NumberH1831794
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2021
Date Manufacturer Received02/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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