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

Model Number IPN046629

Device Problem Obstruction of Flow (2423)

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

Event Date 12/20/2021

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

Anesthesiologist connected the snaplock adapter onto the flextip plus catheter and could not inject medication for pain relief.Once removed the doctor tried to inject again and could not pass any fluid.Customer pulled additional product that was the same lot number and has 14 additional kits that they want to return for credit.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter and snaplock assembly 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 and snaplock assembly 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

Anesthesiologist connected the snaplock adapter onto the flextip plus catheter and could not inject medication for pain relief.Once removed the doctor tried to inject again and could not pass any fluid.Customer pulled additional product that was the same lot number and has 14 additional kits that they want to return for credit.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 13097675
• MDR Text Key: 284820145
• Report Number: 1036844-2021-00183
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 50801902013694
• UDI-Public: 50801902013694
• 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: 12/21/2021

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: 07/31/2022
• Device Model Number: IPN046629
• Device Catalogue Number: SJ-05501
• Device Lot Number: 23F21J0076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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