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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 682142/A
Device Problem Incomplete or Inadequate Connection (4037)
Patient Problem Blood Loss (2597)
Event Date 05/01/2019
Event Type  malfunction  
Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges the blood would back up the tube and leak out of the connection near the red stopcock.When the nurse attempted to tighten the connection it would spin and not get tight.The device was replaced with no injury to the patient.
 
Manufacturer Narrative
The suspect device was returned for evaluation.The device was visually inspected and functional testing was performed.The complaint is confirmed.The root cause is attributed to overtightening of the connection during the procedure.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number 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
76892 6
SN  768926
MDR Report Key8632736
MDR Text Key145838568
Report Number8020616-2019-00040
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,user f
Type of Report Initial,Followup
Report Date 05/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2022
Device Catalogue Number682142/A
Device Lot NumberC1221513
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2019
Date Manufacturer Received05/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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