MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN037306
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the peel-away sheath wing broke off when they went to peel the sheath.No patient harm reported.The patient's condition is reported as fine.
Event or Problem Description
It was reported the peel-away sheath wing broke off when they went to peel the sheath.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one peel-away catheter for analysis.Signs of use in the form of biological material were observed on the sheath surface.Visual analysis revealed that one of the peel-away sheath tabs was separated from the extrusion.Despite this, a portion of the proximal end of the peel-away extrusion was still molded to the tab.The point of separation occurred right at the distal end of the tab.Microscopic examination confirmed the damage and revealed that the point of separation was rough and not uniform.It was also noted that the peel-away sheath was completely split down the score lines.No defects or anomalies were observed with the score lines.The sheath length (per measurement a in the catheter peel-away product drawing) measured 2 13/16", which is within the specification limits of 2 5/8"-2 7/8".The peel away inner and outer diameters could not be accurately measured due to the condition of the returned sample.A manual tug test confirmed that the extrusion was secure to the intact half of the peel-away assembly.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "avoid tearing sheath at insertion site which opens surrounding tissue creating a gap between catheter and dermis".The report that the peel-away sheath tabs broke off during use was confirmed through complaint investigation of the returned sample.Visual analysis revealed that one of the sheath tabs separated from the extrusion.Despite this, a portion of the proximal end of the extrusion was still adhered to the separated tab.The sheath met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, it was observed that the observed failure mode likely occurred during the manufacturing (molding) process.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 14633756
• Report Number: 9680794-2022-00370
• Device Sequence Number: 14932015
• Product Code: LJS
• UDI-Device Identifier: 50801902120781
• UDI-Public: 50801902120781
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2022

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: 02/28/2023
• Device Model Number: IPN037306
• Device Catalogue Number: CDC-45541-VPS2
• Device Lot Number: 13F22A0971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown