MAUDE Adverse Event Report: B BRAUN TEVADAPTER; SYRINGE ADAPTER

Model Number 412118

Device Problems Retraction Problem (1536); Device Inoperable (1663)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/27/2014

Event Type  malfunction  

Event Description

B braun tevadaptor syringe adapter; device failure.When device is disengaged needle fails to retract.This device has been in use at this facility for approx 6 weeks.Ten adaptors have failed, 1 rn sustained a needle stick as a result of the device malfunction.

• Brand Name: TEVADAPTER
• Type of Device: SYRINGE ADAPTER
• Manufacturer (Section D): B BRAUN; rome 0015 3
• MDR Report Key: 4064232
• MDR Text Key: 4858034
• Report Number: MW5038055
• Device Sequence Number: 9
• Product Code: LHI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2014
• 10 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Model Number: 412118
• Device Lot Number: VARIOUS
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1