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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
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Event or Problem Description
Luer lock piece broke off when attaching to the needle.No further information was provided.
 
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Brand Name
NIPRO 10CC SYRINGE WITHOUT NEEDLE
Common Device Name
SYRINGE
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 Key11114682
Report Number1056186-2020-00028
Device Sequence Number11774832
Product Code FMF
UDI-Device Identifier00383790001007
UDI-Public00383790001007
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 01/04/2020
Report Date (Section F) 01/04/2020
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
Operator of Device Health Professional
Device Expiration Date01/31/2024
Device Model NumberJD+10L-WEI
Device Catalogue NumberJD+10L-WEI
Device Lot Number20190218
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date12/14/2020
Event Location Outpatient Treatment Facility
Date Report to Manufacturer01/04/2020
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/04/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Date Report Sent to FDA01/04/2020
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