MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW STIMUCATH SFTY KIT: 19G CTH, 17GX8CM NDL; ANESTHESIA CONDUCTION KIT

Model Number	IPN923943
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported issue: the seal was not complete and the cover came off the tray.
Additional Manufacturer Narrative
(b)(4) the customer returned one opened kit.Visual examination of the returned kit revealed adhesive appears to be sparingly on the outer tray.No other defects or anomalies were observed.A device history record review was performed on the epidural kit with no relevant findings.The reported complaint of the kit not being completely sealed was confirmed based on the sample received.Based upon the information provided and the condition of the sample received, the potential cause of this complaint could not be determined.The returned sample will be returned to the manufacturing site for further evaluation.If the manufacturing site's results become available, this complaint will be reopened and the investigation will be updated.
Event or Problem Description
Reported issue: the seal was not complete and the cover came off the tray.The issue was detected prior to patient use.
Event or Problem Description
Reported issue: the seal was not complete and the cover came off the tray.The issue was detected prior to patient use.
Additional Manufacturer Narrative
(b)(4).Upon further investigation it was determined that the potential cause of the complaint is manufacturing related.A non-conformance was opened to further investigation the issue.*conclusion code has been updated.

• Brand Name: ARROW STIMUCATH SFTY KIT: 19G CTH, 17GX8CM NDL
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16615042
• Report Number: 1036844-2023-00019
• Device Sequence Number: 17420710
• Product Code: CAZ
• UDI-Device Identifier: 10801902207392
• UDI-Public: 10801902207392
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K121403
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2023

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: 02/01/2024
• Device Model Number: IPN923943
• Device Catalogue Number: AB-19608-KS
• Device Lot Number: 37F22H0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 04/17/2023; 06/09/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/19/2023; 06/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown