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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 TB 1CC 25GX5/8"

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SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO MCKESSON BRANDS SYRINGE/NDL TB 1CC 25GX5/8" Back to Search Results
Catalog Number 16-SNT1C2558
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Event Description
The medical provider communicated that several patients had developed infections at the site of administration post different types of vaccine administration. The medical provider stated that she believed the needles were the common factor.
 
Manufacturer Narrative
The medical provider communicated orally with her mckesson medical surgical account representative prior to october 12, 2021 that several of her patients had developed infections at the site of administration post different types of vaccine administration within the last 6 months. The medical provider shortly after the oral conversation, provided information via email on october 12, 2021 that she believed that the mckesson labeled needles/syringes were the common factor and may be the reason for the development of these infections that resulted in abscesses. The medical provider did not provide any product lot information regarding the mckesson labeled needle/syringes nor any patient specific information regarding the adverse events. Based upon our review of shipment data for the defined time period the medical provider received two different types of needles/syringes under the mckesson label as well as two different becton dickinson labeled needles/syringes distributed by mckesson medical surgical. As a result of this complaint, we are filing an mdr for each type of the mckesson labeled needle/ syringe products received by the medical provider.
 
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Brand NameMCKESSON BRANDS
Type of DeviceSYRINGE/NDL TB 1CC 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 Key13534173
MDR Text Key287529289
Report Number1451040-2022-00006
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 02/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number16-SNT1C2558
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/14/2022
Distributor Facility Aware Date10/12/2021
Device Age12 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer01/27/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/15/2022 Patient Sequence Number: 1
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