MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION SET: 19 GA; ANESTHESIA CONDUCTION CATHETER

Model Number IPN046378

Device Problem Disconnection (1171)

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

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that, "the doctor found tube disconnected when using on patient.Then changed new one, no impact on patient".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

Event Description

It was reported that, "the doctor found tube disconnected when using on patient.Then changed new one, no impact on patient".Additional information received indicates the snaplock was found disconnected and the whole device was replaced.

Manufacturer Narrative

(b)(4).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 a potentially relevant finding on the snaplock assembly where the outer diameter for the extrusion was out of specification.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.Other remarks: n/a.Corrected data: n/a.

Manufacturer Narrative

(b)(4).The reported complaint of the snaplock assembly disconnecting from the catheter could not be confirmed based on the sample received.The customer returned one piece of an epidural catheter.No snaplock assembly was returned.The returned sample was visually examined with and without magnification.Visual examination of the returned catheter piece revealed the proximal end of the catheter was returned and was intact.The returned catheter piece reveals the catheter appeared to have been cut at the likely most distal end.The catheter appeared as used.Biological material could be seen between the inner coils and adhesive material could be seen on the outer extrusion.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter piece using a calibrated ruler.The returned catheter extrusion measured approximately 61.3cm.This indicated at least 27.2cm of the extrusion was missing as the specification for the epidural catheter indicated that the proper extrusion length of an epidural catheter was 88.5-91.5cm per product graphic.Functional inspection could not be performed based on the condition of the returned epidural catheter.The ifu provided with this kit cautions the user," do not alter the catheter or any other kit/set component during insertion, use or removal (except as instructed)." a device history record review was performed on the epidural catheter and snaplock assembly with a potentially relevant finding based on the od being out of spec, for which further investigation has already been initiated.Based on the customer report and the sample received, the root cause of this complaint could not be determined at the time of this report.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that, "the doctor found tube disconnected when using on patient.Then changed new one, no impact on patient".Additional information received indicates the snaplock was found disconnected and the whole device was replaced.

• Brand Name: EPIDURAL CATHETERIZATION SET: 19 GA
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16806416
• MDR Text Key: 313913027
• Report Number: 3006425876-2023-00468
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10801902128406
• UDI-Public: 10801902128406
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2023

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: 11/30/2023
• Device Model Number: IPN046378
• Device Catalogue Number: EC-05400-E
• Device Lot Number: 71F21M0560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 05/19/2023; 07/25/2023
• Supplement Dates FDA Received: 05/24/2023; 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1