MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASY TOUCH; SYRINGE, 1ML CC

Model Number	802015
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the shape of the plunger of the syringe provided in the ancillary convenience kit is causing an inaccurate measurement of vaccine.The customer stated that they measured the syringes against others used in the past and claim that there is a disparity in the accuracy of the dosages.Customer stated that while drawing up 6 dosages, medication was still left in the vial, for example the dosage should be 0.3 but due to the extra stopper pull resulted in a dosage amount of less than 0.3.
Additional Manufacturer Narrative
Mckesson medical-surgical, inc.Is the assembler of convenience kits that can contain the syringe component identified in part d of this report.The item ref # and lot # reported and identified have been confirmed as having been used in the assembly of convenience kits supplied by mckesson medical-surgical, inc.We have notified asprsnsopscell@cdc.Gov and barda-rqaproductacceptance@hhs.Gov for awareness.

• Brand Name: EASY TOUCH
• Common Device Name: SYRINGE, 1ML CC
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 8695 seward rd.; fairfield OH 45011
• Manufacturer (Section G): MCKESSON MEDICAL-SURGICAL, INC.; 9954 mayland drive; richmond VA 23233
• Manufacturer Contact: jo ann silverthorne ; 9954 mayland drive; richmond, VA 23233 ; 8045532278
• MDR Report Key: 14687625
• Report Number: 3017368639-2022-00024
• Device Sequence Number: 19993540
• Product Code: FMF
• UDI-Device Identifier: MHC18020151
• UDI-Public: MHC18020151
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/09/2026
• Device Model Number: 802015
• Device Lot Number: 54471
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown