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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE SAFEDRAW TRANSDUCER SET; BLOOD PRESSURE TRANSDUCER SET
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MERIT MEDICAL SINGAPORE SAFEDRAW TRANSDUCER SET; BLOOD PRESSURE TRANSDUCER SET Back to Search Results
Catalog Number 689491/JPA
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/28/2021
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.The pm set was exchanged, and the procedure was successfully completed.No patient injury to report.
 
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
SAFEDRAW TRANSDUCER SET
Type of Device
BLOOD PRESSURE TRANSDUCER SET
Manufacturer (Section D)
MERIT MEDICAL SINGAPORE
198 yishun ave 7
singapore, 76892 6
SN  768926
MDR Report Key12174189
MDR Text Key261991756
Report Number8020616-2021-00043
Device Sequence Number1
Product Code DSK
UDI-Device Identifier04589867113482
UDI-Public4589867113482
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 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/08/2024
Device Catalogue Number689491/JPA
Device Lot NumberC2045108
Was Device Available for Evaluation? No
Date Manufacturer Received07/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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