MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC SPINAL ANES/EPIDURAL CATH KIT; ANESTHESIA CONDUCTION CATHETER

Model Number IPN045667

Device Problem No Flow (2991)

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

Event Date 03/09/2022

Event Type  malfunction  

Event Description

Approximately 13 instances in the month of march 2 were found to be unable to push medications through after being placed.The doctor's initial texts which were forwarded to marketing and engineering: just wondering whether y'all have changed the polyurethane material around the wire reinforced catheter.It seems stiffer and keeps causing parasthesias.We are having a lot of problems with the catheters.Kinks, clots, cannot thread, or too tough.The patient is fine.

Manufacturer Narrative

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

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.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 with no evidence to indicate a manufacturing related issue.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without a sample.No further action is required at this time.

Event Description

Approximately 13 instances in the month of march 2 were found to be unable to push medications through after being placed.The doctor's initial texts which were forwarded to marketing and engineering: just wondering whether y'all have changed the polyurethane material around the wire reinforced catheter.It seems stiffer and keeps causing parasthesias.We are having a lot of problems with the catheters.Kinks, clots, cannot thread, or too tough.The patient is fine.

• Brand Name: SPINAL ANES/EPIDURAL CATH 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13923952
• MDR Text Key: 288295669
• Report Number: 1036844-2022-00021
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 00801902075130
• UDI-Public: 00801902075130
• 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: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: IPN045667
• Device Catalogue Number: ASK-05401-LMC
• Device Lot Number: 23F22A0010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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 Sex: Female