MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM; CATHETER INTRAVSCULAR THERAPEU

Model Number	IPN037301
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
Customer reported the picc line was leaking from the junction of the clear tubing and the pink luer hub.Early in the morning it was functioning appropriately for a lab draw, but on assessment prior to use for an infusion, it was noted to leak.The line had been placed on (b)(6) 2023.No patient harm was reported.The patient's condition is reported as fine.
Event or Problem Description
Customer reported the picc line was leaking from the junction of the clear tubing and the pink luer hub.Early in the morning it was functioning appropriately for a lab draw, but on assessment prior to use for an infusion, it was noted to leak.The line had been placed on (b)(6) 2023.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one 2-l catheter for analysis.Definite signs of use were observed on the catheter body and within the extension lines.Visual analysis revealed one hole on the distal extension line directly adjacent to the luer hub.The remainder of the extension line was secure within the luer hub.The distal end of the catheter body also appeared to be intentionally severed.No other defects or anomalies were identified.The overall length of the catheter measured 16 1/4" which is not within the specification limits of 22 6/8" - 23" per the catheter product drawing.This indicates that at least 6.5" was not returned for analysis.The distal extension line outer diameter measured 0.09515" which is within the specification limits of 0.093" - 0.097" per the extension line product drawing.The distal extension line inner diameter measured 0.057" which is within the specification limits of 0.055" - 0.059" per the extension line product drawing.The catheter was functionally tested per the instructions for use (ifu) provided with this kit which states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." both extension lines were attached to a lab inventory syringe and flushed.The proximal extension line flushed as intended, but water was seen leaking out of the hole in the distal extension line.A manual tug test confirmed that both extension lines were secure within their luer hubs.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage." the customer report of an extension line leak was confirmed through investigation of the returned sample.A hole was found in the distal extension line directly adjacent to the luer hub.The catheter passed all relevant dimensional requirements, and a device history record review was performed with no relevant findings.The type of damage observed is consistent with a manufacturing issue in the picc lines, therefore, manufacturing likely caused or contribute to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend reports of this nature.

• Brand Name: ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM
• Common Device Name: CATHETER INTRAVSCULAR THERAPEU
• 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: 16742307
• Report Number: 9680794-2023-00268
• Device Sequence Number: 6379292
• Product Code: LJS
• UDI-Device Identifier: 30801902120794
• UDI-Public: 30801902120794
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2023

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: 11/30/2023
• Device Model Number: IPN037301
• Device Catalogue Number: CDC-45552-VPS2
• Device Lot Number: 13F22K0450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown