MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC G4 STYLET: 2L 5.5FR X 55CM BP; CATHETER INTRAVASCULAR THERAPE

Catalog Number	DLX-45552-VPSB
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one 2-l picc for analysis.Signs-of-use were observed on the catheter body and inside the extension lines.The catheter appeared to be intentionally severed.Visual inspection of the returned catheter revealed a small hole in the distal extension line.The hole was located adjacent to the luer hub.The catheter body measured 16.5" which is not within the specifications of 22"-22.75".This indicates that at least 5.5" of the catheter were severed and not returned.The distal extension line outer diameter (od) measured 0.09359" which is within the specifications of 0.093"-0.097.The distal extension line inner diameter (id) measured 0.057" which is within the specifications of 0.055"-0.059".This indicates that the wall thickness measured within specifications.Functional inspection of the catheter was performed per the instructions-for-use (ifu) provided with the kit which states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the catheter lumens were attached to a lab inventory 10ml syringe and flushed.Water was observed exiting the hole in the distal extension line.The proximal line flushed normally, with no leaks or blockages observed.A manual tug test confirmed the proximal extension line was secure to its luer hub.All complaints are trended across product families on a monthly basis.The instructions-for-use (ifu) provided with the kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained, and further consultation requested." a non-conformance was initiated to further investigate this issue.The customer report of an extension line leak was confirmed through complaint investigation of the returned sample.Visual inspection revealed a small hole in the distal extension line, adjacent to the luer hub which is consistent with a molding defect.Based on these circumstances, manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "line was leaking where the lumen meets the pink hub.Line was in for 6 months." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW AGBA PICC G4 STYLET: 2L 5.5FR X 55CM BP
• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19220218
• Report Number: 9680794-2024-00331
• Device Sequence Number: 12810558
• Product Code: LJS
• UDI-Device Identifier: 10801902208627
• UDI-Public: 10801902208627
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K123759
• 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
• Report Date (Section B): 03/21/2024

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 Catalogue Number: DLX-45552-VPSB
• Device Lot Number: 33F23F0573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown