MAUDE Adverse Event Report: 3ML LL SYRINGE MIS 18GX1.5; SYRINGE PISTON

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2019

Event Type  malfunction  

Event Description

Pt reports 1 syringe "malfunctioned" however, pt did not waste their medication nor miss any doses.

• Brand Name: 3ML LL SYRINGE MIS 18GX1.5
• Type of Device: SYRINGE PISTON
• MDR Report Key: 9530165
• MDR Text Key: 173190965
• Report Number: MW5091936
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 08290309580
• UDI-Public: 08290309580
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 91 YR