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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO MCKESSON BRANDS SYRINGE/NDL LL 3CC 25GX5/8"

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SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO MCKESSON BRANDS SYRINGE/NDL LL 3CC 25GX5/8" Back to Search Results
Catalog Number 16-SN3C2558
Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)
Patient Problem Needle Stick/Puncture (2462)
Event Date 08/13/2021
Event Type  malfunction  
Event Description
The customer reported that the needles bend and that they are having trouble getting them through stoppers to draw up injectables and sometimes go through a couple just to draw up an injection. They reported a needle stick following recapping. It was also reported that the needles leak from the side. No information was received regarding any serious injury.
 
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Brand NameMCKESSON BRANDS
Type of DeviceSYRINGE/NDL LL 3CC 25GX5/8"
Manufacturer (Section D)
SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO
no. 658, gao chao rd., jiading
shanghai, shanghai 20180 3
CH 201803
MDR Report Key12369860
MDR Text Key268210370
Report Number1451040-2021-00014
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 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number16-SN3C2558
Device Lot NumberCKDJ10-04
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/25/2021
Distributor Facility Aware Date08/13/2021
Device Age10 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer08/25/2021
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: 08/26/2021 Patient Sequence Number: 1
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