MAUDE Adverse Event Report: ARROW; CATHETER, CONDUCTION, ANESTHETIC

Model Number	IPN045729
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Large leak noted in epidural catheter proximal to snap-lock adapter, after test dose administered.Catheter removed w/o injury to pt.Another kit opened and successfully administered epidural w/o difficulty.

• Brand Name: ARROW
• Common Device Name: CATHETER, CONDUCTION, ANESTHETIC
• MDR Report Key: 12473746
• Report Number: 12473746
• Device Sequence Number: 17328158
• Product Code: BSO
• UDI-Device Identifier: 10801902114430
• UDI-Public: (01)10801902114430(17)220430(10)23F21EOO17
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/13/2021
• Report Date (Section F): 09/13/2021

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 Model Number: IPN045729
• Device Catalogue Number: ASK-17019-SM
• Device Lot Number: 23F21EOO17
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Weight: 71
• Date Report Sent to FDA: 09/13/2021