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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 688683
Device Problem Fluid/Blood Leak (1250)
Patient Problem Blood Loss (2597)
Event Date 09/29/2019
Event Type  Injury  
Manufacturer Narrative
The 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 pressure monitoring device was placed on (b)(6) 2019.On (b)(6) 2019, the device leaked approximately 8 ml of blood and saline from the connection between the transducer and stopcock.No patient injury was reported.
 
Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually, and functional testing was performed.The complaint could not be confirmed.The root cause could not be determined.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 Key9242428
MDR Text Key164151732
Report Number8020616-2019-00119
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 10/02/2019
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 Number688683
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2019
Initial Date Manufacturer Received 10/02/2019
Initial Date FDA Received10/25/2019
Supplement Dates Manufacturer Received11/06/2019
Supplement Dates FDA Received11/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age17 DA
Patient Weight2
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