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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 689312/B
Device Problem Fluid/Blood Leak (1250)
Patient Problem Blood Loss (2597)
Event Date 04/24/2019
Event Type  malfunction  
Manufacturer Narrative
The suspect device has returned for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that blood was leaking near the septum.No patient injury reported.
 
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 one similar complaint for this lot number was 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 Key8640176
MDR Text Key146073864
Report Number8020616-2019-00041
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 05/03/2019
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 Date08/31/2020
Device Catalogue Number689312/B
Device Lot NumberC1397947
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2019
Initial Date Manufacturer Received 05/03/2019
Initial Date FDA Received05/24/2019
Supplement Dates Manufacturer Received05/31/2019
Supplement Dates FDA Received06/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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