MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG B. BRAUN 25 GAUGE SPINAL NEEDLE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Lot Number 0061618036

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 04/30/2019

Event Type  Injury  

Event Description

A 25 gauge spinal anesthesia needle broke off during attempted epidural anesthesia prior to a c-section.Retained needle portion had to be surgically removed.Retained portion measured 4.5 cm in length and 0.1 cm in diameter.A second epidural had to be initiated for the pt to proceed with c-section.Fda safety report id# (b)(4).

• Brand Name: B. BRAUN 25 GAUGE SPINAL NEEDLE
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG
• MDR Report Key: 8616174
• MDR Text Key: 145480878
• Report Number: MW5086693
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0061618036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 22 YR