MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC KIT: 1L 4.5 FR X 55 CM VPS; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	ASK-45541-UWH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "luer lock clear plastic piece broke off inside underneath the blue cap".This malfunction was found prior to use.No patient harm or injury.
Event or Problem Description
It was reported "luer lock clear plastic piece broke off inside underneath the blue cap".This malfunction was found prior to use.No patient harm or injury.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one stylet assembly, including one tuohy borst , and syringe for analysis.No definite signs of use were observed on the returned components.Visual analysis revealed no obvious defects or anomalies with the returned components.The returned side port adapter was functionally tested per the vps instruction booklet , which instructs the user, "flush stylet lumen attach saline filled syringe to luer of side port adapter and flush adapter and catheter.Clamp side port extension and remove syringe." the stylet was inserted through the tuohy borst and the tuohy borst was tightened on the stylet.The assembly was then flushed using the returned 10cc syringe, and the assembly flushed as intended.No leaking or cracks were observed.The vps instruction booklet provided as part of a general ask-45541-uwh kit informs the user, "warning: use care when tightening the tuohy borst to minimize the risk of blood loss and air embolism.".The customer report of a separated hub was not confirmed through investigation of the returned sample.The returned adapter passed all relevant visual and functional requirements.Based on the customer report and the sample received, no problem was found.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW PICC KIT: 1L 4.5 FR X 55 CM VPS
• 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: 18601081
• Report Number: 9680794-2024-00062
• Device Sequence Number: 2662440
• Product Code: LJS
• UDI-Device Identifier: 10801902161731
• UDI-Public: 10801902161731
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 01/10/2024

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 Catalogue Number: ASK-45541-UWH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; NONE REPORTED
• Patient Sex: Unknown