MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. / TELEFLEX FLEX TIP PLUS EPIDURAL CATH KIT; ANESTHESIA CONDUCTION KIT

Catalog Number	SJ-05501
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Labor patient had epidural inserted by crna without difficulty.No issues during labor and after vaginal delivery of healthy baby.When the ob rn went to remove the epidural catheter, it broke, with 5 inches remaining in the epidural space.Ob rn noted tip at end not intact and one inch of tubing without coating, only wire present.

• Brand Name: FLEX TIP PLUS EPIDURAL CATH KIT
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. / TELEFLEX; reading PA 19605
• MDR Report Key: 7658228
• Report Number: MW5078200
• Device Sequence Number: 19213343
• Product Code: CAZ
• UDI-Device Identifier: 00801902013699
• UDI-Public: (01)00801902013699
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: SJ-05501
• Device Lot Number: 23F17K0443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 19 YR
• Patient Weight: 59