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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW BLOOD SAMPLING SYSTEM
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MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW BLOOD SAMPLING SYSTEM Back to Search Results
Catalog Number 688650
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2019
Event Type  malfunction  
Manufacturer Narrative
The suspect device has been returned 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 at the connections before use.The pm set was exchanged for a new set and the monitoring successfully completed.No patient injury to report.
 
Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined visually.The complaint is confirmed.The root cause was attributed to significant force being applied to the device during use.A review of the device history and complaint database could not be performed since the lot number was not provided.
 
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Brand Name
SAFEDRAW BLOOD SAMPLING SYSTEM
Type of Device
BLOOD SAMPLING SYSTEM
Manufacturer (Section D)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, 76892 6
SN  768926
MDR Report Key9292656
MDR Text Key195469699
Report Number8020616-2019-00133
Device Sequence Number1
Product Code DSK
Combination Product (y/n)N
PMA/PMN Number
K885235
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/15/2019
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 Number688650
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2019
Initial Date Manufacturer Received 10/15/2019
Initial Date FDA Received11/07/2019
Supplement Dates Manufacturer Received11/26/2019
Supplement Dates FDA Received12/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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