MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC G4 STYLET: 1L 4.5FR X 55CM TCG; CATHETER INTRAVASCULAR THERAPE

Catalog Number	DLX-45541-VPSC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "one of our team members brought me a broken arrowg+ard blue single lumen picc this afternoon.It appears to have separated at the top of the wing after the patient had discharged from the facility.The line had been approximately 1 month and it was not on removal.She still had two weeks of antibiotics so we placed another picc.There were no problems reported before this." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "one of our team members brought me a broken arrowg+ard blue single lumen picc this afternoon.It appears to have separated at the top of the wing after the patient had discharged from the facility.The line had been approximately 1 month and it was not on removal.She still had two weeks of antibiotics so we placed another picc.There were no problems reported before this." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one, single-lumen picc and connector tubing for analysis.Signs of use were observed on the catheter body.Visual analysis revealed that the extension line was severed adjacent to the juncture hub.Microscopic examination confirmed the damage and revealed that the edges are smooth and uniform, which is damage consistent with damage resulting from contact with a sharp instrument (i.E.Scissors, scalpel, etc).The point of separation measured 53mm from the luer hub and 1mm from the juncture hub.The distal extension line outer diameter measured 0.0935", which is within the specification limits of 0.0930"-0.0970" per the distal extension line extrusion product drawing.The distal extension line inner diameter at the point of separation measured 0.056", which is within the specification limits 0.055"-0.059" per the distal extension line extrusion product drawing.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations".The report of a separated extension line was confirmed through complaint investigation.Visual analysis revealed that extension line was severed adjacent to the juncture hub.The appearance of the separation is consistent with damage resulting from contact with a sharp object (i.E.Scissors, scalpel, etc.).Despite the damage, all relevant dimensional requirements were met, and a device history record review did not reveal any relevant findings to suggest a manufacturing related issue.Based on the customer report that the defect occurred during use and the appearance of the damage, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PICC G4 STYLET: 1L 4.5FR X 55CM TCG
• 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: 20836114
• Report Number: 9680794-2024-01189
• Device Sequence Number: 11770383
• Product Code: LJS
• UDI-Device Identifier: 10801902208610
• UDI-Public: (01)10801902208610(11)240416(17)251031(10)33F24B0527(21)
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K122545
• 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): 11/10/2024

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: 10/31/2025
• Device Catalogue Number: DLX-45541-VPSC
• Device Lot Number: 33F24B0527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2024
• 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: Unknown