MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET: 2-LUMEN 5 FR X 19-1/2" (50 CM); CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-05052
Medical Device Problem Codes	Crack (1135); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the patient is admitted to the icu to perform a picc insertion procedure in the left upper limb basilic vein, by a trained senior nurse.During the procedure, after inserting the peel-away, it is observed to have fissured distally, obstructing catheter passage.The unit is immediately removed, and a new kit is requested from the pharmacist." the patient's current condition is reported as "fine".
Event or Problem Description
It was reported "the patient is admitted to the icu to perform a picc insertion procedure in the left upper limb basilic vein, by a trained senior nurse.During the procedure, after inserting the peel-away, it is observed to have fissured distally, obstructing catheter passage.The unit is immediately removed, and a new kit is requested from the pharmacist." the patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The complaint of a peel-away sheath split prematurely was able to be confirmed by the photo.The image shows a used peel-away sheath with the body peeling distal to the tabs.The extrusion at the tabs appears intact.The device is designed to peel from the tabs, which is the proximal end of the sheath; therefore, the image indicates a potential extrusion issue.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "withdraw peel-away sheath over catheter until sheath hub and connected portion of sheath is free from venipuncture site.Grasp tabs of peel-away sheath and pull away from the catheter, while withdrawing from vessel until sheath splits down its entire length." the ifu also states, "precaution: avoid tearing sheath at insertion site which opens surrounding tissue creating a gap between catheter and dermis.".The customer report of a peel-away sheath splitting prematurely was confirmed by visual inspection of the customer supplied photo.The image shows a used peel-away sheath with the body peeling distal to the tabs, and the extrusion at the tabs was intact.The device is designed to peel from the tabs, which is the proximal end of the sheath; therefore, the image indicates a potential manufacturing extrusion issue.Based on these circumstances and the customer photo, the probable root cause is likely manufacturing related.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PICC SET: 2-LUMEN 5 FR X 19-1/2" (50 CM)
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• 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: 19271694
• Report Number: 9680794-2024-00432
• Device Sequence Number: 7034507
• Product Code: LJS
• UDI-Device Identifier: 10801902095371
• UDI-Public: 10801902095371
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K042126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: PR-05052
• Device Lot Number: 14F23J0238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Age: 36 YR
• Patient Sex: Male