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

Model Number IPN040163

Device Problem Premature Separation (4045)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending and a follow-up report will be issued after the investigation is completed.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that on (b)(6) 2022 in the obstetric block during childbirth, the wingclip snaplock separated from the filter.The consequence was a leak of the treatment and the non-administration of the patient's epidural analgesia.This interruption lasted 1 hour whilst cleaning and replacing the catheter.It cause a risk for the patient.The patient's condition was reported as fine.

Manufacturer Narrative

Qn# (b)(4).A device history record review was performed on the flat filter and snaplock assembly with no relevant findings.The customer reported the filter disconnected from the snaplock.The customer returned one flat filter, one snaplock assembly, and an epidural catheter.The filter and snaplock were received connected.The returned components were visually examined with and without magnification.Visual examination of the returned filter and snaplock assembly revealed both components were typical with no observed defects or anomalies.Visual examination of the returned catheter revealed that the catheter appears used as biological material can be seen on the inner coils and adhesive can be seen on the outer extrusion.No other defects or anomalies were observed.Functional inspection was performed on the returned sample.The male lock connector of the returned filter was connected to the returned snaplock assembly and hand tightening the rotating collar to the snaplock assembly with no issues.An attempt to remove the rotating collar from the male lock connector of the returned filter was performed.Using hand pressure, the rotating collar could not be removed even with much effort.In summary, the reported complaint of the filter disconnecting from the snaplock could not be confirmed based on the sample received.A flat filter and snaplock assembly were returned.Using hand pressure, the returned filter's collar could not be removed from the male lock connector even with much effort.Also, there were no connection issues when connecting the returned filter to the returned snaplock assembly.A device history record review was performed on the epidural catheter and snaplock assembly with no relevant findings.The investigation found no evidence to suggest a manufacturing related cause.Based on the functional testing, there was no issues found with the returned sample.No further action is required at this time.

Event Description

It was reported that on (b)(6) 2022 in the obstetric block during childbirth, the wingclip snaplock separated from the filter.The consequence was a leak of the treatment and the non-administration of the patient's epidural analgesia.This interruption lasted 1 hour whilst cleaning and replacing the catheter.It cause a risk for the patient.The patient's condition was reported as fine.

• Brand Name: EPIDURAL CATHETERIZATION SET
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15692043
• MDR Text Key: 306806640
• Report Number: 3006425876-2022-00983
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 30801902126420
• UDI-Public: 30801902126420
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

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: 05/31/2024
• Device Model Number: IPN040163
• Device Catalogue Number: JC-05400-E
• Device Lot Number: 71F22F1932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 10/28/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/13/2022
• 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
• Treatment: N/A.
• Patient Outcome(s): Required Intervention