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

Device Problem Material Twisted/Bent (2981)

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

Event Date 01/24/2020

Event Type  malfunction  

Event Description

Pt called in to report that one of the needle tips is bent.She states that the product is "cheap".We changed the syr / needle to 28g 1ml 1/2" for the pt and she is ok with that.

• Brand Name: SYRINGE TUBERCU 27GX1/2 1CC
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD
• MDR Report Key: 9654278
• MDR Text Key: 177584305
• Report Number: MW5092672
• 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: Other
• Type of Report: Initial
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• 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: 58 YR