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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD NIPRO SYRINGE WITH NEEDLE

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SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD NIPRO SYRINGE WITH NEEDLE Back to Search Results
Model Number JD+10L2025-WEI
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/24/2019
Event Type  Injury  
Event Description
Syringe tip broke off in the venous portion of the permanent dialysis catheter while being prepped for treatment. The staff was unable to remove the syringe tip and the patient was sent to the emergency room for removal and replacement of the permanent dialysis catheter. No further information was provided.
 
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Brand NameNIPRO SYRINGE WITH NEEDLE
Type of DeviceSYRINGE WITH NEEDLE
Manufacturer (Section D)
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD
20 xingshan road
address2 hight tech industrial
267-2 019
CH 267-2019
MDR Report Key9569361
MDR Text Key174331031
Report Number1056186-2019-00022
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 01/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJD+10L2025-WEI
Device Lot Number20190610
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/09/2020
Distributor Facility Aware Date12/09/2019
Device Age5 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer01/09/2020
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: 01/09/2020 Patient Sequence Number: 1
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