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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW TRANSDUCER SET; BLOOD PRESSURE TRANSDUCER SET
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MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW TRANSDUCER SET; BLOOD PRESSURE TRANSDUCER SET Back to Search Results
Catalog Number 688910
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2021
Event Type  Injury  
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 set was found to be leaking fluid close to the planecta.The pm set was replaced.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.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Corrected complaint data: "the account alleges that during the hemodynamic monitoring of a picu patient, the pressure monitoring set was found to be leaking fluid from the connection of male/female luer connectors between the blood pressure transducer and cap.The pm set was replaced.No patient injury to report.
 
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Brand Name
SAFEDRAW TRANSDUCER SET
Type of Device
BLOOD PRESSURE TRANSDUCER SET
Manufacturer (Section D)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, sgp 76892 6
SN  768926
MDR Report Key12232903
MDR Text Key264974680
Report Number8020616-2021-00045
Device Sequence Number1
Product Code DSK
UDI-Device Identifier04589867113482
UDI-Public4589867113482
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number688910
Was Device Available for Evaluation? No
Date Manufacturer Received08/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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