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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 689290/JPA
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/01/2019
Event Type  malfunction  
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 during a pressure monitoring [pm] procedure on an icu patient, the pm set was purposely disconnected to change the patient's clothes.When the pm set was reconnected for use, air was purged from the pm set line.When returning saline back into the line, the marvelous stopcock septum was found to be leaking.No patient injury to report.
 
Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually and tested for leaks.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 Key8363835
MDR Text Key137006161
Report Number8020616-2019-00018
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 02/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number689290/JPA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2019
Date Manufacturer Received04/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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