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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 688639
Device Problem Fluid/Blood Leak (1250)
Patient Problem Blood Loss (2597)
Event Date 11/27/2018
Event Type  malfunction  
Manufacturer Narrative
The suspect device has returned for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that during a pressure monitoring procedure, a leak was found between the planecta stop cock and the tubing that connects to the patient.The set was replaced.No patient injury to report.
 
Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually.The complaint is confirmed.The root cause is attributed to the manufacturing process.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 Key8190090
MDR Text Key131177101
Report Number8020616-2018-00090
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 11/28/2018
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 Number688639
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2018
Initial Date Manufacturer Received 11/28/2018
Initial Date FDA Received12/21/2018
Supplement Dates Manufacturer Received01/31/2019
Supplement Dates FDA Received02/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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