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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD NIPRO 10CC SYRINGE WITHOUT NEEDLE

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SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD NIPRO 10CC SYRINGE WITHOUT NEEDLE Back to Search Results
Model Number JD+10L-WEI
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
When the staff connects the syringe to the heparin line, avf needle luer lock, and dialysis catheter, the luer lock tip breaks off. No further information was provided.
 
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Brand NameNIPRO 10CC SYRINGE WITHOUT NEEDLE
Type of DeviceSYRINGE
Manufacturer (Section D)
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD
20 xingshan road
hight tech industrial
development, weihai 267-2 09
CH 267-209
MDR Report Key11114487
MDR Text Key225345516
Report Number1056186-2020-00027
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJD+10L-WEI
Device Catalogue NumberJD+10L-WEI
Device Lot Number20190908
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/04/2020
Distributor Facility Aware Date12/14/2020
Event Location Outpatient Treatment Facility
Date Report to Manufacturer01/04/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/04/2021 Patient Sequence Number: 1
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