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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
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MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Catalog Number 689549/JPA
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2021
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 the device began to leak fluid near the sensor.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
Type of Device
SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, 76892 6
SN  768926
MDR Report Key11584329
MDR Text Key243650423
Report Number8020616-2021-00015
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Type of Report Initial,Followup
Report Date 03/05/2021
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 Catalogue Number689549/JPA
Device Lot NumberC1819196
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/05/2021
Initial Date FDA Received03/29/2021
Supplement Dates Manufacturer Received03/26/2021
Supplement Dates FDA Received04/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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