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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW BLOOD SUPPLY SYSTEM
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MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW BLOOD SUPPLY SYSTEM Back to Search Results
Catalog Number 688555
Device Problem Fluid/Blood Leak (1250)
Patient Problem Blood Loss (2597)
Event Date 11/26/2018
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 a gap was identified between the planecta and the female luer causing the device to leak while priming the pressure monitoring set for use.No patient injury to report.
 
Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually.The complaint could not be confirmed.The root cause could not be determined.A review of the device history record and complaint database could not be performed since the lot number was not provided.
 
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Brand Name
SAFEDRAW BLOOD SUPPLY SYSTEM
Type of Device
BLOOD SUPPLY SYSTEM
Manufacturer (Section D)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, 76892 6
SN  768926
MDR Report Key8170899
MDR Text Key130545740
Report Number8020616-2018-00086
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 11/27/2018
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 Number688555
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2018
Initial Date Manufacturer Received 11/27/2018
Initial Date FDA Received12/17/2018
Supplement Dates Manufacturer Received02/01/2019
Supplement Dates FDA Received02/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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