MAUDE Adverse Event Report: B. BRAUN; TRANSFER NEEDLE, DOUBLE ENDED

Model Number DN1017

Device Problems Break (1069); Detachment Of Device Component (1104); Sticking (1597)

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

Event Date 11/16/2015

Event Type  malfunction  

Event Description

B.Braun double ended transfer needle used in preparing iv's is breaking off and part still sticking in the vial.Then med cannot be drawn out.Product doe is (b)(4), lot #61444907.Exp: (b)(6) 2020.

• Type of Device: TRANSFER NEEDLE, DOUBLE ENDED
• Manufacturer (Section D): B. BRAUN; bethlehem PA 18018 3524
• MDR Report Key: 5276948
• MDR Text Key: 33263058
• Report Number: MW5058384
• Device Sequence Number: 1
• 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: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: DN1017
• Device Catalogue Number: 415017
• Device Lot Number: 61444907
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1