MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 3L 6FRX55CM W/80CM HYDRO NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-35563-HPHNM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported: "picc inserted through sheath and when they cracked peel away sheath to pull it apart, the white plastic part at the end broke off.Sheath was able to be removed and picc remained insitu.There was no reported patient harm or consequence".
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one peel-away sheath for evaluation.Signs of use were observed.Visual inspection of the peel-away sheath revealed that one side of the peel away sheath extrusion was separated adjacent to the tab.Remains of the extrusion were still attached to the separated tab.One side of the sheath was split completely down the extrusion.The sheath was additionally severed to observe the cross section.The sheath body length from the tabs to the distal tip measured 4", which is within the specification limits of 3 7/8" - 4 1/8" per peel-away product drawing.The outer diameter of the sheath measured 0.1123" which is within the specification limits of 0.112-0.122" per the peel-away product drawing.A device history record review was performed and no relevant findings were identified.The ifu provided with the kit informs the user, "precaution: avoid tearing sheath at insertion site which opens surrounding tissue creating a gap between catheter and dermis." the report of a broken peel away sheath tab was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the sheath extrusion had separated directly adjacent to one tab.A device history record review was performed and no relevant findings were identified.Based on the customer report and the sample received, manufacturing likely 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: "picc inserted through sheath and when they cracked peel away sheath to pull it apart, the white plastic part at the end broke off.Sheath was able to be removed and picc remained insitu.There was no reported patient harm or consequence.".

• Brand Name: ARROW PI PICC 3L 6FRX55CM W/80CM HYDRO NIT SWG
• 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: 20105258
• Report Number: 9680794-2024-00819
• Device Sequence Number: 8475100
• Product Code: LJS
• UDI-Device Identifier: 00801902095657
• UDI-Public: (01)00801902095657(11)230921(17)250831(10)33F23H0476(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K080604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2024

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: PR-35563-HPHNM
• Device Lot Number: 33F23H0476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2024
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown