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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 C1303670
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/10/2018
Event Type  malfunction  
Manufacturer Narrative
The device has returned for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that while prepping a pressure transducer set for the hemodynamic monitoring of a patient, the set was found to be leaking at the planecta.No patient injury to report.
 
Manufacturer Narrative
The suspect device was not returned for evaluation, however, an unused unit from the same lot was returned.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 complaints for this lot number were 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 Key8277442
MDR Text Key134085343
Report Number8020616-2019-00009
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 01/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2020
Device Catalogue NumberC1303670
Device Lot Number688420/B
Was Device Available for Evaluation? No
Date Returned to Manufacturer01/17/2019
Date Manufacturer Received02/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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