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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 689128/JPA
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2021
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 during the hemodynamic monitoring of a patient, the pressure monitoring [pm] set was found to be leaking fluid close to the planecta.The pm set was replaced.No patient injury to report.
 
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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, sgp 76892 6
SN  768926
Manufacturer (Section G)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, sgp 76892 6
SN   768926
Manufacturer Contact
bryson heaton
1600 merit parkway
south jordan, UT 84095
8012084662
MDR Report Key11791006
MDR Text Key249541032
Report Number8020616-2021-00026
Device Sequence Number1
Product Code DXN
UDI-Device Identifier00884450356098
UDI-Public884450356098
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K935782
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 04/08/2021
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 Expiration Date11/29/2023
Device Catalogue Number689128/JPA
Device Lot NumberC1989793
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/08/2021
Initial Date FDA Received05/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/15/2020
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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