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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD. VSI BAND CLAMP, VASCULAR

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LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD. VSI BAND CLAMP, VASCULAR Back to Search Results
Model Number 3529
Device Problem Air Leak (1008)
Patient Problem Hemostasis (1895)
Event Date 09/15/2016
Event Type  Injury  
Manufacturer Narrative
Returned product was evaluated, test result demonstrated that there was air leak. It could be seen a symmetrical damage on the valve, which might be caused by pincers. Physician was asked through the distributor and stated no pincers were used to clamp the valve. In addition, manufacturing process was also reviewed, there was no such tool used during the manufacturing process. The root cause cannot be determined.
 
Event Description
Dr. Was putting on the vasc band and it would slowly start to lose pressure and patient kept bleeding. Thinks it is the air valve vs the balloon since it lost air slowly.
 
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Brand NameVSI BAND
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD.
no.37, chaoqian road,
changping district
beijing, 10220 0
CH 102200
Manufacturer (Section G)
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD.
no.37, chaoqian road,
changping district
beijing, 10220 0
CH 102200
Manufacturer Contact
bo jiang
no.37, chaoqian road
changping district
beijing, 10220-0
CH   102200
1381034605
MDR Report Key6408873
MDR Text Key70065996
Report Number3008002401-2017-00001
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142359
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 02/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/19/2018
Device Model Number3529
Device Catalogue NumberN.A.
Device Lot Number201605006
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/16/2017 Patient Sequence Number: 1
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