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

Lot Number 0061782587

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/16/2021

Event Type  Injury  

Event Description

Spinal needle broke while being used for spinal analgesia.Fda safety report id # (b)(4).

• Brand Name: PENCAN SPINAL NEEDLE TRAY
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
• MDR Report Key: 13087523
• MDR Text Key: 282889993
• Report Number: MW5106280
• 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: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Lot Number: 0061782587
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White