MAUDE Adverse Event Report: ARROW INTERNATIONAL, LLC. (SUBSIDIARY OF TELEFLEX INCORPORATED) FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number ASK-05501-GH

Patient Problem Foreign Body In Patient (2687)

Event Date 02/13/2024

Event Type  malfunction  

Event Description

Epidural catheter sheared during final positioning.Left in place until after delivery.This issue was with the product itself.The catheter sheared while being pulled back (not through the needle and not a difficult removal, as is typically the case).Catheter was removed by neurosurgery.Flex tip plus epidural cath kit by arrow.Ref ask-05501-gh.Lot 37f22j0008.

• Brand Name: FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): ARROW INTERNATIONAL, LLC. (SUBSIDIARY OF TELEFLEX INCORPORATED)
• MDR Report Key: 18788534
• MDR Text Key: 336475412
• Report Number: MW5152014
• Device Sequence Number: 1
• Product Code: BSO
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASK-05501-GH
• Device Lot Number: 37F22J0008
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American