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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. DTX SAFEDRAW PM KITS; PRESSURE MONITORING SET
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MERIT MEDICAL SINGAPORE PTE LTD. DTX SAFEDRAW PM KITS; PRESSURE MONITORING SET Back to Search Results
Catalog Number 689367/B
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2021
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 that leakage was coming from an unspecified location on the device.No patient injury to report.
 
Manufacturer Narrative
The suspect device was returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.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
DTX SAFEDRAW PM KITS
Type of Device
PRESSURE MONITORING SET
Manufacturer (Section D)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, 76892 6
SN  768926
MDR Report Key11406394
MDR Text Key246663001
Report Number8020616-2021-00009
Device Sequence Number1
Product Code DXN
UDI-Device Identifier00884450356098
UDI-Public884450356098
Combination Product (y/n)N
PMA/PMN Number
K935782
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2024
Device Catalogue Number689367/B
Device Lot NumberC1498200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2021
Date Manufacturer Received03/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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