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

Catalog Number	ASK-05500-SC1
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "while placing an epidural, clinician utilized the 30 ga injection needle within their kit.When the clinician was advancing the needle , it then broke off inside of the patient.The patient now had to get a scan to see where the needle was, so they could safely remove it.Additional information: "the patient is fine and healthy now.The needle broke off, so it had to be surgically removed by a neurosurgeon.It was uncomfortable for the patient.".
Additional Manufacturer Narrative
(b)(4).The reported complaint of the 30ga injection needle breaking during use could not be confirmed based on the sample received.The actual complaint sample was not returned; only a representative sample was received.Visual inspection of the returned sample revealed no defects or anomalies observed.The customer also provided photos that appear to show a broken injection needle and x-ray.A device history record review was performed on the 30ga injection syringe with no relevant findings.The potential cause of this complaint could not be determined based upon the information provided and without the actual sample.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that: "while placing an epidural, clinician utilized the 30 ga injection needle within their kit.When the clinician was advancing the needle, it then broke off inside of the patient.The patient now had to get a scan to see where the needle was, so they could safely remove it.Additional information: "the patient is fine and healthy now.The needle broke off, so it had to be surgically removed by a neurosurgeon.It was uncomfortable for the patient.".

• Brand Name: ARROW EPIDURAL CATHETERIZATION KIT: 19 GA
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21854152
• Report Number: 9680794-2025-00319
• Device Sequence Number: 18347395
• Product Code: BSO
• UDI-Device Identifier: 10801902114331
• UDI-Public: (01)10801902114331(11)250128(17)261231(10)33F24L0567(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ASK-05500-SC1
• Device Lot Number: 33F24L0567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown