MAUDE Adverse Event Report: DUOPROSS MEDITECH CORPORATION DPS BARE HYPODERMIC SYRINGE 1ML; SYRINGE, PISTON

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 03/19/2021

Event Type  malfunction  

Event Description

Per report from staff at site, when a student nurse was attempting to inject a second dose of moderna covid vaccine, the syringe came apart and the dose was wasted.Given reports of prior issues with the haiou syringe, i would like to report this syringe in case there have been other incidents: needle and syringe information: mckesson 25g x1" needle, dps bare hypodermic syringe 1ml.This event was also reported on vaers and to the covid call center.Fda safety report id # (b)(4).

• Brand Name: DPS BARE HYPODERMIC SYRINGE 1ML
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): DUOPROSS MEDITECH CORPORATION
• MDR Report Key: 11581134
• MDR Text Key: 242986985
• Report Number: MW5100312
• Device Sequence Number: 1
• Product Code: FMF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR