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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
Model Number 682000
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/09/2020
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 blood leaked from a marvelous 3-way stopcock.It was found when 8 or 12 hours had passed since the placement of the unit, and when a nurse on the night shift performed blood collection and returned blood from a syringe of the product to a patient.The complaint unit was replaced.No major problem and no patient injury occurred on the patient.
 
Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
 
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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, sgp 76892 6
SN  768926
MDR Report Key10335870
MDR Text Key202213194
Report Number8020616-2020-00040
Device Sequence Number1
Product Code DSK
UDI-Device Identifier00886333620005
UDI-Public00886333620005
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 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number682000
Device Catalogue Number689401
Was Device Available for Evaluation? No
Date Manufacturer Received08/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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