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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE SAFEDRAW BLOOD PRESSURE TRANSDUCER SET; COMPUTER, BLOOD-PRESSURE

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MERIT MEDICAL SINGAPORE SAFEDRAW BLOOD PRESSURE TRANSDUCER SET; COMPUTER, BLOOD-PRESSURE Back to Search Results
Catalog Number 689312/B
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/11/2023
Event Type  Injury  
Event Description
The account alleges that after replacing the a-line on the pressure monitoring device for a neonatal patient, the nurse noticed that the a-line was leaking blood.The device was exchanged for a new one and the procedure was completed without consequence to the patient.
 
Manufacturer Narrative
The suspect medical device will not be returning for engineering evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.
 
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 BLOOD PRESSURE TRANSDUCER SET
Type of Device
COMPUTER, BLOOD-PRESSURE
Manufacturer (Section D)
MERIT MEDICAL SINGAPORE
198 yishun ave 7
singapore, 76892 6
SN  768926
Manufacturer (Section G)
MERIT MEDICAL SINGAPORE
198 yishun ave 7
singapore, 76892 6
SN   768926
Manufacturer Contact
bryson heaton bsn,rn.
1600 merit parkway
south jordan, UT 84095
MDR Report Key17353649
MDR Text Key319385753
Report Number8020616-2023-00042
Device Sequence Number1
Product Code DSK
UDI-Device Identifier00884450356357
UDI-Public884450356357
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
EXEMPT
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 07/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number689312/B
Device Lot NumberC2531619
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/11/2023
Initial Date FDA Received07/19/2023
Supplement Dates Manufacturer Received07/21/2023
Supplement Dates FDA Received07/25/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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