MAUDE Adverse Event Report: ARROW TELEFLEX ARROW TELEFLEX EPIDURAL NEEDLE

Model Number SJ-05501

Device Problem Bent (1059)

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

Event Date 01/12/2017

Event Type  Injury  

Event Description

Anesthesiologist was inserting a teleflex/arrow epidural needle in order to thread in a catheter to administer epidural drug, the needle bent upon insertion.

• Brand Name: ARROW TELEFLEX EPIDURAL NEEDLE
• Type of Device: ARROW TELEFLEX EPIDURAL NEEDLE
• Manufacturer (Section D): ARROW TELEFLEX ; reading PA 19605
• MDR Report Key: 6260611
• MDR Text Key: 65310055
• Report Number: MW5067301
• Device Sequence Number: 1
• Product Code: BSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: SJ-05501
• Device Catalogue Number: SJ-05501
• Device Lot Number: 23F16J0801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 59