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

Model Number	AK-05503
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Pt had episodes for pain control and upon removal of the epidural catheter the tip was noted to be missing and was not seen on x-ray.There is no evidence of radiopaque foreign body to suggest retained fragment.Soft tissues unremarkable.Skeletal structures intact.Fda safety report id# (b)(4).

• Brand Name: ARROW FLEX TIP PLUS EPIDURAL CATHETER
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.
• MDR Report Key: 9341390
• Report Number: MW5091154
• Device Sequence Number: 2722233
• Product Code: BSO
• UDI-Device Identifier: 70801902005143
• UDI-Public: (01)70801902005143
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/14/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: AK-05503
• Device Catalogue Number: AK-05503
• Device Lot Number: 23F19G0272
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 110