MAUDE Adverse Event Report: UNKNOWN SYRINGE TUBERCU 27GX1/2 1CC; SYRINGE, PISTON

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/24/2019

Event Type  Injury  

Event Description

Per patient, needle keeps falling off while withdrawing medication.

• Brand Name: SYRINGE TUBERCU 27GX1/2 1CC
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9250112
• MDR Text Key: 164830068
• Report Number: MW5090753
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 08290309623
• UDI-Public: 08290309623
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR