MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. B BRAUN SPINAL NEEDLE TRAY; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Model Number P25BK

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/13/2024

Event Type  Injury  

Event Description

Spinal anesthetic.Small portion of the tip of the spinal needle from the spinal block broke.And subsequent xr shows retained fragment near lumbar spinous process.No apparent harm to patient at this time.

Event Description

Additional information received on 4/4/2024 for report mw5152064 to correct spelling to mfr name.

• Brand Name: B BRAUN SPINAL NEEDLE TRAY
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; bethlehem PA 18018
• MDR Report Key: 18798635
• MDR Text Key: 336559170
• Report Number: MW5152064
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/03/2014

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 Model Number: P25BK
• Device Lot Number: 333851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/04/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Female