MAUDE Adverse Event Report: JIANGSU SHENLI MEDICAL PRODUCTION CO., LTD. DPS BARE HYPODERMIC SYRINGE; SYRINGE, 1ML

Model Number 9SL01001

Device Problem Incorrect Measurement (1383)

Patient Problem Insufficient Information (4580)

Event Date 05/16/2022

Event Type  malfunction  

Manufacturer Narrative

Mckesson medical-surgical, inc.Is the assembler of convenience kits that can contain the syringe component identified in 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.

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.

• Brand Name: DPS BARE HYPODERMIC SYRINGE
• Type of Device: SYRINGE, 1ML
• Manufacturer (Section D): JIANGSU SHENLI MEDICAL PRODUCTION CO., LTD.; no. 20, changzheng rd., zenglu; tianning district; changzhou, jiangsu 21311 1; CH 213111
• 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: 14687707
• MDR Text Key: 302059652
• Report Number: 3017368639-2022-00023
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 06935550810011
• UDI-Public: 06935550810011
• 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

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9SL01001
• Device Lot Number: SL201101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• 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