MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ACCESS TRAY; SALINE VASCULAR ACCESS FLUSH

Catalog Number	ASK-04001-VCUH3
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "peel away did not tear correctly, the distal tip did not separate, the clinician had to use forceps to remove distal end of sheath from the body of the picc during the insertion.They were able to remove the peel away and complete the procedure without further incident.This was the 3rd incident related to this same incomplete tearing issue.There was no reported patient harm or consequence." associated complaints: 9680794-2024-01004, and 9680794-2024-01003.
Additional Manufacturer Narrative
(b)(4).The customer returned one peel-away sheath for analysis.Signs of use in the form of biological material were observed on the sheath extrusion and tabs.Visual inspection revealed that the sheath extrusion didn't tear at the score lines towards the tip, confirming that the sheath was torn incorrectly.Microscopic examination confirmed the damage and revealed that the sheath was torn completely down both score lines.It was additionally noted that the tear at the score lines was partially scalloped, which is not the intended appearance of the score lines once torn.The total length of the sheath measured 2 3/4", which is within the specification limits of 2 5/8 - 2 7/8" per the sheath product drawing.The sheath outer and inner diameters could not be accurately measured due to the nature of the damage.Functional testing could not be performed due to the condition of the returned sample.A device history record review was performed, and no relevant findings were identified.The report that a peel-away did not tear correctly was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the sheath didn't tear down the score lines at the tip.The appearance of the torn score lines was also scalloped which is not the sheath's intended appearance.Based on the customer report and the sample received, manufacturing caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "peel away did not tear correctly, the distal tip did not separate, the clinician had to use forceps to remove distal end of sheath from the body of the picc during the insertion.They were able to remove the peel away and complete the procedure without further incident.This was the 3rd incident related to this same incomplete tearing issue.There was no reported patient harm or consequence." associated complaints: 9680794-2024-01004, and 9680794-2024-01003.

• Brand Name: ARROW ACCESS TRAY
• Common Device Name: SALINE VASCULAR ACCESS FLUSH
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20309044
• Report Number: 9680794-2024-01005
• Device Sequence Number: 12939629
• Product Code: NGT
• UDI-Device Identifier: 10801902214895
• UDI-Public: (01)10801902214895(11)240215(17)250831(10)33F24A0512(21)
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K192414
• 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): 09/16/2024

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: 08/31/2025
• Device Catalogue Number: ASK-04001-VCUH3
• Device Lot Number: 33F24A0512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2024
• 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.
• Patient Sex: Female