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

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.

• Brand Name: MCKESSON BRANDS
• Type of Device: 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
• MDR Text Key: 287529289
• Report Number: 1451040-2022-00006
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Report Sent to FDA: 02/14/2022
• Distributor Facility Aware Date: 10/12/2021
• Device Age: 12 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other