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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 687603/JPA
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/21/2018
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 the distal connector was found to be disconnected while prepping the pressure transducer set for the hemodynamic monitoring of a patient.The set was replaced.No injury to report.
 
Manufacturer Narrative
The suspect device was returned for evaluation.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.
 
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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 Key8276534
MDR Text Key134061855
Report Number8020616-2019-00012
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 12/26/2018
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 Date07/31/2020
Device Catalogue Number687603/JPA
Device Lot NumberC1387630
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2019
Initial Date Manufacturer Received 12/26/2018
Initial Date FDA Received01/24/2019
Supplement Dates Manufacturer Received03/18/2019
Supplement Dates FDA Received03/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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