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

Catalog Number	DLX-45552-VPSC
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: lumen was drawing back air instead of only blood while line was indwelling in patient the reported defect was detected during use on patient.The patient condition was reported as "fine" post-procedure.Medical intervention reported states: catheter was replaced.
Additional Manufacturer Narrative
Qn#(b)(4).The report of a leaking catheter body was not confirmed through complaint investigation of the returned sample.The customer returned one, 2-lumen picc catheter/vps/buddy assembly for analysis.Signs-of-use in the form of biological material were observed on the catheter and within the extension lines.Visual analysis revealed the distal end of the catheter was severed, and it is assumed the catheter was intentionally severed.No other signs of defects or anomalies were observed on the catheter.The catheter body length from the juncture hub to the severed end measured 35.8 cm via calibrated ruler, which was not within the specification limits of 55.86-57.77 cm per the catheter product drawing, therefore, at least 20.06 cm of the catheter body was severed and not returned.The catheter body outer diameter measured 0.07315" via calibrated micrometer, which was within the specification limits of 0.069"-0.074" per the catheter extrusion product drawing.Functional inspection was performed per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".The stylet was removed from the pink extension line.A lab inventory syringe filled with water was attached to both extension lines and flushed.When flushing both extension lines, no leaks or backflow were observed.The returned catheter was then tested per bs en iso which states that there shall be no liquid leakage in the form of one or more falling drops when pressurized to 300 kpa for 30 seconds.The device was connected to lab leak tester and pressurized to 300 kpa for 30 seconds with the distal end occluded.The extension lines were connected individually to the leak tester, and when pressurized, no catheter backflow or leaks were detected from any portion of the catheter, which indicates no interlumen crossover was observed.Based on this testing, the customer issue could not be reproduced with the returned sample.A manual tug test confirmed that the extension lines were secure within their respective luer hubs.The ifu provided with the kit informs the user, "ensure catheter patency prior to use, including prior to pressure injection.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture.Flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." a device history record review was performed, and no relevant findings were identified.Based on the customer report and the testing of the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: lumen was drawing back air instead of only blood while line was indwelling in patient.The reported defect was detected during use on patient.The patient condition was reported as "fine" post-procedure.Medical intervention reported states: catheter was replaced.

• Brand Name: ARROW AGBA PICC G4 STYLET: 2L 5.5FR 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18474669
• Report Number: 9680794-2024-00045
• Device Sequence Number: 6924172
• Product Code: LJS
• UDI-Device Identifier: 10801902208634
• UDI-Public: 10801902208634
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K123759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/15/2023

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
• Device Expiration Date: 12/31/2024
• Device Catalogue Number: DLX-45552-VPSC
• Device Lot Number: 33F23G0083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• 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