MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER

Catalog Number AK-05503-L

Device Problem Sharp Edges (4013)

Patient Problem Spinal Column Injury (2081)

Event Date 05/12/2022

Event Type  Injury  

Event Description

Physician reported that due to sharpness of the needle in the ak-05503- l was a contributing factor to dura puncture.A wet tap occurred and a blood patch had to be placed.

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was provided for analysis.A device history record review was performed on the epidural needle with no evidence to suggest a manufacturing related cause.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

Physician reported that due to sharpness of the needle in the ak-05503- l was a contributing factor to dura puncture.A wet tap occurred and a blood patch had to be placed.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 14489198
• MDR Text Key: 292518545
• Report Number: 1036844-2022-00033
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: AK-05503-L
• Device Lot Number: 23F22B0086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female