MAUDE Adverse Event Report: BD BD 1CC TB; SYRINGE, ANTISTICK

Model Number 306623

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354); Device Slipped (1584); Device Operates Differently Than Expected (2913)

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

Event Date 03/08/2016

Event Type  malfunction  

Event Description

Per our event report: "we've had several problems with bd 1ml tb syringes, slip tip with db precisionglide needles (ref: 309623).The entire hub comes off of the syringe barrel when trying to remove the cap from the needle.So, naturally, you push the hub back on very tight and then try to remove the cap again.Your hand is likely to bounce back may cause a needle stick.We've had tuberculin leak from the hub of the syringe during preparation.It's very difficult to assess the amount of tuberculin in the barrel." i have had multiple reports of issues with this device.All syringes with problems have been discarded.I tested 2 syringes myself, on both the needle/hub detached from the syringe when attempting to remove the needle cap - lot#'s on the ones i tested (b)(4), other#'s on the packaging (b)(4).Manufacturer response for 1cc tb syringe, bd (per site reporter): will call them as soon as i'm done with this entry.

• Brand Name: BD 1CC TB
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): BD; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 5519298
• MDR Text Key: 40945420
• Report Number: 5519298
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 306623
• Device Catalogue Number: 306623
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1