MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION KIT: 19 GA; ANESTHESIA CONDUCTION CATHETER

Catalog Number AK-05501

Device Problem Failure to Advance (2524)

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

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The doctor said that he thinks the internal wire in the epidural catheter is kinking/binding up when trying to push through the needle causing (unknown).

Event Description

The doctor said that he thinks the internal wire in the epidural catheter is kinking/binding up when trying to push through the needle causing (unknown).

Manufacturer Narrative

Qn# (b)(4).A device history record review was performed on the epidural catheter and needle with no relevant findings.A design history review was performed for part # kz-05500-007 and kz-005400-030 as a part of this complaint investigation.There have been no material changes for these parts during the last two years that could have led to this complaint.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural catheter and needle with no relevant findings.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.

• Brand Name: EPIDURAL CATHETERIZATION KIT: 19 GA
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• MDR Report Key: 12459846
• MDR Text Key: 271021523
• Report Number: 1036844-2021-00157
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

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 Expiration Date: 04/30/2022
• Device Catalogue Number: AK-05501
• Device Lot Number: 23F21E0064
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/13/2021
• Supplement Dates Manufacturer Received: 10/11/2021
• Supplement Dates FDA Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• 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