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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. MERIT CUSTOM MANIFOLD
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MERIT MEDICAL SYSTEMS INC. MERIT CUSTOM MANIFOLD Back to Search Results
Model Number 193127
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/06/2020
Event Type  malfunction  
Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account reported a defect in the packaging.This was identified during their initial inspection of the received product.The device was not used.No patient contact.
 
Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to rough handling through shipping and handeling.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.
 
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Brand Name
MERIT CUSTOM MANIFOLD
Type of Device
MANIFOLD
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC.
1600 merit parkway
south jordan,, ut
MDR Report Key10119511
MDR Text Key199488511
Report Number1721504-2020-00031
Device Sequence Number1
Product Code DQO
UDI-Device Identifier00886333207060
UDI-Public00886333207060
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 05/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/06/2023
Device Model Number193127
Device Catalogue Number503HN-R/CN
Device Lot NumberH1739066
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2020
Date Manufacturer Received06/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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