MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EPIDURAL ANESTHESIA KIT; ANESTHESIA CONDUCTION KIT

Catalog Number	SM-03001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the customer reported the kits had broken sodium chloride bottles inside.The customer returned ten sealed kits from the same lot # reported for investigation.The actual complaint sample was not received.Each sealed kit was opened and visually examined.Visual examination of all ten kits revealed none of the ampules in the kit appear to be damaged or broken.The reported complaint of the kit having broken sodium chloride bottles inside could not be confirmed based on the sample received.A device history record review was performed on the saline solution ampule and the epidural kit with no relevant findings.The investigation found no evidence to suggest a manufacturing related cause.Based on the visual inspection, there were no issues found with the returned sample.No further action is required at this time.
Event or Problem Description
It was reported that: "we have had some kits all had broken sodium chloride bottles in the kits.The liquid was dried up but there were shards of glass in the kit.All with the same lot number".Associated complaints 9680794-2025-00881, 9680794-2025-00886, 9680794-2025-00888, 9680794-2025-00889, 9680794-2025-00890, 9680794-2025-00891, 9680794-2025-00893, 9680794-2025-00894, 9680794-2025-00884, 9680794-2025-00885 and 9680794-2025-00880.

• Brand Name: ARROW EPIDURAL ANESTHESIA KIT
• Common Device Name: ANESTHESIA CONDUCTION KIT
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23434931
• Report Number: 9680794-2025-00892
• Device Sequence Number: 17339050
• Product Code: CAZ
• UDI-Device Identifier: 10801902013832
• UDI-Public: (01)10801902013832(11)250505(17)260630(10)33F25B0128(21)
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K884552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2025

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: 06/30/2026
• Device Catalogue Number: SM-03001
• Device Lot Number: 33F25B0128
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2025
• 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
• Patient Sex: Unknown