MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. BRAUN PENCAN SPINAL NEEDLE TRAY; NEEDLE, CONDUCTION, ANESTHETIC

Model Number NOT AVAILABLE

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

Patient Problem Foreign Body In Patient (2687)

Event Date 04/02/2019

Event Type  Injury  

Event Description

During administration of spinal anesthesia, 1.5-2 inches of the spinal needle broke off and was lodged in the subcutaneous tissue.Patient required surgery to remove the needle.Packaging was not available.

• Brand Name: BRAUN PENCAN SPINAL NEEDLE TRAY
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.
• MDR Report Key: 8794454
• MDR Text Key: 151357909
• Report Number: MW5088165
• 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: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NOT AVAILABLE
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Required Intervention
• Patient Age: 68 YR