MAUDE Adverse Event Report: SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO MCKESSON BRANDS; SYRINGE/NDL TB 1CC 25GX5/8"

Catalog Number	16-SNT1C2558
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.

• Brand Name: MCKESSON BRANDS
• Common Device Name: SYRINGE/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 Key: 13534173
• Report Number: 1451040-2022-00006
• Device Sequence Number: 5392105
• Product Code: FMF
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• 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): 02/14/2022
• Report Date (Section F): 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 16-SNT1C2558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/12/2021
• Device Age: 12 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/27/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/14/2022