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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. DTX SAFEDRAW; BLOOD PRESSURE TRANSDUCER

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MERIT MEDICAL SINGAPORE PTE LTD. DTX SAFEDRAW; BLOOD PRESSURE TRANSDUCER Back to Search Results
Catalog Number 689369/B
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2023
Event Type  malfunction  
Event Description
The account alleges that during use, the arterial line was found to have a leak above the dome towards the patient.This caused blood to leak out of the arterial line from the patient and onto the ground.No additional patient consequence to report.
 
Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the investigation is complete.
 
Manufacturer Narrative
The suspect device was not 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
Type of Device
BLOOD PRESSURE TRANSDUCER
Manufacturer (Section D)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, 76892 6
SN  768926
Manufacturer (Section G)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, 76892 6
SN   768926
Manufacturer Contact
bryson heaton
1600 merit parkway
south jordan, UT 84095
MDR Report Key17267369
MDR Text Key318515319
Report Number8020616-2023-00041
Device Sequence Number1
Product Code DSK
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K885235
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number689369/B
Device Lot NumberC2513002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/30/2023
Initial Date FDA Received07/06/2023
Supplement Dates Manufacturer Received07/09/2023
Supplement Dates FDA Received07/11/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/11/2022
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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