MAUDE Adverse Event Report: EPIDURAL NEEDLE; ANESTHESIA CONDUCTION KIT

Catalog Number AN-02017

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Complained about bending of needle, tensile strength not strong enough, theory that heat treatment was not being done properly to harden the needle.

Manufacturer Narrative

Qn# (b)(4).A device history record review could not be performed as no lot number was provided by the customer.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed as no lot number was provided by the customer.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without the sample.No further action is required at this time.

Event Description

Complained about bending of needle, tensile strength not strong enough, theory that heat treatment was not being done properly to harden the needle.

• Brand Name: EPIDURAL NEEDLE
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 11842972
• MDR Text Key: 251234615
• Report Number: 1036844-2021-00096
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K884552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

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 Catalogue Number: AN-02017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 06/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1