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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 688410/B
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/05/2018
Event Type  malfunction  
Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that during a hemodynamic monitoring procedure the pm set was found to be leaking at a septum connection.The defective device was discarded by the account.No patient injury to report.
 
Manufacturer Narrative
The suspect device was not returned for evaluation.Only eight unused units from the same lot were returned.The devices were examined visually and functional testing was performed.The complaint is confirmed.The root cause is attributed to the manufacturing process.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 complaint for this lot number was found.Corrective actions are in process.
 
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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 Key8028848
MDR Text Key125922842
Report Number8020616-2018-00062
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 10/09/2018
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 Expiration Date05/31/2020
Device Catalogue Number688410/B
Device Lot NumberC1331463
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2018
Initial Date Manufacturer Received 10/09/2018
Initial Date FDA Received11/01/2018
Supplement Dates Manufacturer Received11/29/2018
Supplement Dates FDA Received12/07/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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