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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported picc that was leaking from the luer hub/tubing connection.It was reported the picc also had intermittent issues with flushing and "subq kink" noted (captured in mdr # 9680794-2022-00164).The picc line was replaced with a new picc.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported picc that was leaking from the luer hub/tubing connection.It was reported the picc also had intermittent issues with flushing and "subq kink" noted (captured in mdr# 9680794-2022-00164).The picc line was replaced with a new picc.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one, 1-lumen picc catheter for analysis.Signs of use in the form of biological material was observed inside the catheter extension line.It was noted that the catheter body was intentionally severed and the severed portion was not returned for analysis.Visual analysis revealed that the distal extension line contains a hole directly adjacent to the luer hub (pink hub).Microscopic examination confirmed the damage and revealed that the extension line was still molded within the luer hub.The catheter body length from the juncture hub to the distal tip measured 15 1/4" which indicates that 7 1/2- 7 3/4" of the catheter body was severed and not returned for analysis (per product drawing.The outer diameter of the distal extension line measured.0965" which is within the specification limits of.093"-.097" per the distal extension line extrusion graphic.The distal extension line inner diameter measured.058" which is within the specification limits of.055"-.059" per the distal extension line extrusion graphic.The ifu provided with the kit informs the user, "attach pre-filled saline syringe, if provided , or other syringe to sidearm and flush distal lumen with sterile saline solution.Leave syringe in place.Flush remaining lumen(s) with sterile saline.Clamp or attach injection site cap(s) to extension line(s) to contain saline within lumen".The catheter extension line was attached to a lab inventory arrow raulerson syringe (ars).The syringe plunger was flushed, and water was observed leaking out of the hole in the distal extension line.A device history record review was performed, and a potentially relevant finding was identified.Two non-conformances were initiated for lot numbers 13c20f1225 and 13c21h1829 regarding extension line leaking.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter.Excessive force can cause catheter breakage.If placement or withdrawal cannot be easily accomplished, an x-ray should be obtained and further consultation requested".The ifu also states, "open catheter clamp prior to infusion through lumen to reduce risk of damage to extension line(s) from excessive pressure".The customer report of a leaking extension line was confirmed through complaint investigation.Visual and functional analysis revealed that the distal extension line contained a hole directly adjacent to the luer hub.Despite this, the catheter met all relevant dimensional requirements.Based on the customer report and the sample received , it was determined that manufacturing caused or contributed to this event.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: 13638749
• Report Number: 9680794-2022-00118
• Device Sequence Number: 14721543
• Product Code: LJS
• UDI-Device Identifier: 50801902120781
• UDI-Public: 50801902120781
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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): 02/07/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: IPN037306
• Device Catalogue Number: CDC-45541-VPS2
• Device Lot Number: 13F21J1114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2021
• 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: TPA (TISSUE PLASMINOGEN ACTIVATOR); TPA (TISSUE PLASMINOGEN ACTIVATOR)
• Patient Sex: Unknown