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

Lot Number 7087647

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2018

Event Type  malfunction  

Event Description

Pt had difficulty getting caps off syringes, some she couldn't use at all.Husband tried too, almost sticking himself trying to pry caps off."is the product compounded: no, is the product over-the-counter: yes.".

• Brand Name: SYRINGE TUBERCU 27GX1/2 1CC
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 7596281
• MDR Text Key: 111138330
• Report Number: MW5077820
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 08290309623
• UDI-Public: 08290309623
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/09/2018

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: No Information
• Device Expiration Date: 03/31/2022
• Device Lot Number: 7087647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR