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

Model Number IPN923943

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Reported issue: the seal was not complete and the cover came off the tray.

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 Description

Reported issue: the seal was not complete and the cover came off the tray.The issue was detected prior to patient use.

Event Description

Reported issue: the seal was not complete and the cover came off the tray.The issue was detected prior to patient use.

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
• Type of Device: 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
• MDR Text Key: 312132636
• Report Number: 1036844-2023-00019
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 10801902207392
• UDI-Public: 10801902207392
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED; NONE REPORTED