MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) AVANOS EPIDURAL TUOHY NEEDLE 20G; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Lot Number 30099939

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/06/2022

Event Type  malfunction  

Event Description

Patient brought to procedure room for epidural blood patch.Upon removal of epidural needle from patient's back, it became evident that a portion of the needle had broken off and remained in the patient's back.Interventional radiology physicians were called to procedure room and were able to successfully remove the broken portion of the needle from the patient.Fda safety report id # (b)(4).

• Brand Name: AVANOS EPIDURAL TUOHY NEEDLE 20G
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 15732622
• MDR Text Key: 303173547
• Report Number: MW5113070
• 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: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 30099939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 159 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American