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

Model Number	IPN046311
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Involved a female patient who was in maternity room.The lor syringe does not identify the loss of resistance during the procedure of insertion of the epidural catheter.With physiological saline, the syringe stiffened and resistance occured leading to a dural breach.Additional information: patient went home.A blood patch was applied and analgesics paracetamol plus ibuprofene.The device is not available for investigation.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Involved a female patient who was in maternity room.The lor syringe does not identify the loss of resistance during the procedure of insertion of the epidural catheter.With physiological saline, the syringe stiffened and resistance occured leading to a dural breach.Additional information: patient went home.A blood patch was applied and analgesics paracetamol plus ibuprofen.The device is not available for investigation.
Additional Manufacturer Narrative
(b)(4).A device history record review was performed on the lor syringe with no relevant findings.A design history review was performed for part # kz-05501-002 as a part of this complaint investigation.There have been no material changes for this part during the last two years that could have led to this complaint.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual sample.Complaint verification testing could not be performed as no sample was provided for analysis.A device history record review was performed on the lor syringe 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.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Common Device Name: 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: 13915357
• Report Number: 3006425876-2022-00278
• Device Sequence Number: 14550679
• Product Code: BSO
• UDI-Device Identifier: 00801902029676
• UDI-Public: 00801902029676
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: IPN046311
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F21J1424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 03/26/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown