MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED) ARROW EZ-IO; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number REF 9079-VC-005 (PN033767)

Device Problems Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 01/18/2022

Event Type  malfunction  

Event Description

Faulty intraosseous needle, inserted with gun; during insertion needle bent when removed, noted needle split 3 ways.Fda safety report id# (b)(4).

• Brand Name: ARROW EZ-IO
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED)
• MDR Report Key: 13358512
• MDR Text Key: 284618654
• Report Number: MW5106968
• Device Sequence Number: 1
• Product Code: FMI
• 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: 01/21/2022

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 Expiration Date: 05/31/2024
• Device Model Number: REF 9079-VC-005 (PN033767)
• Device Catalogue Number: NSN 6515-01-577-0312
• Device Lot Number: 6899577
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female