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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 682051
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/27/2019
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 blood leaked from the set and during manipulation of the device the white part of the septum dislodged from the blue plastic containing it.The device was switched to a new one with no injury to the patient.
 
Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined visually.The complaint is confirmed.The root cause is attributed to the manufacturing process.A review of the device history and complaint database could not be performed since the lot number was not provided.
 
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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
76892 6
SN  768926
MDR Report Key8831572
MDR Text Key156659384
Report Number8020616-2019-00067
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 07/03/2019
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 Catalogue Number682051
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2019
Initial Date Manufacturer Received 07/03/2019
Initial Date FDA Received07/26/2019
Supplement Dates Manufacturer Received10/14/2019
Supplement Dates FDA Received10/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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