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

Model Number 802015

Device Problem Incorrect Measurement (1383)

Patient Problem Insufficient Information (4580)

Event Date 05/16/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 301551313
• Report Number: 3017368639-2022-00024
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: MHC18020151
• UDI-Public: MHC18020151
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 802015
• Device Lot Number: 54471
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other