MAUDE Adverse Event Report: ARROW INTERNATIONAL, LLC FLEXTIP PLUS EPIDURAL CATHETER; ANESTHESIA CONDUCTION KIT

Lot Number 13F22D0513

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/15/2022

Event Type  Injury  

Event Description

Epidural catheter lodged and unable to remove.Catheter broke off in patient when removed under fluoroscopy.The incident was reported to the manufacturer.Catheter will be returned to the manufacturer.Fda safety report id# (b)(4).

• Brand Name: FLEXTIP PLUS EPIDURAL CATHETER
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL, LLC
• MDR Report Key: 14855359
• MDR Text Key: 295050554
• Report Number: MW5110581
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Lot Number: 13F22D0513
• 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 Age: 23 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White