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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW BLOOD SAMPLING SET
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MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW BLOOD SAMPLING SET Back to Search Results
Catalog Number 689623/JPB
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/22/2019
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 that during the hemodynamic monitoring of a patient, the pressure monitoring set was damaged during patient transfer when the bed collided with an anesthesia machine.A support clip was damaged causing the pm tubing to separate and leak.The event was immediately handled by medical professionals.No patient injury to report.
 
Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed.The root cause is attributed to the manufacturing process.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.
 
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Brand Name
SAFEDRAW BLOOD SAMPLING SET
Type of Device
BLOOD SAMPLING SET
Manufacturer (Section D)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, 76892 6
SN  768926
MDR Report Key8913115
MDR Text Key156658386
Report Number8020616-2019-00078
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 07/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number689623/JPB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2019
Date Manufacturer Received10/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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