MAUDE Adverse Event Report: ARROW EPIDURAL KIT; FLEX TIP PLUS CATHETER

Model Number HS-05501

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2017

Event Type  Injury  

Event Description

Arrow epidural catheterization kit with flextip plus catheter product no.Hs-05501 fractured when removing the catheter from the patient.This occurred with 3 patients.Lot number 23f17-a0560 was removed from clinical area as well as all other lot numbers until issue is resolved.Patient received epidural catheters for total joint replacement, (b)(6) 2017.

• Brand Name: EPIDURAL KIT
• Type of Device: FLEX TIP PLUS CATHETER
• Manufacturer (Section D): ARROW; louisville KY 40241
• MDR Report Key: 6442316
• MDR Text Key: 71267354
• Report Number: MW5068720
• Device Sequence Number: 2
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/27/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: HS-05501
• Device Lot Number: 23F17A0560
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR