MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAP

Catalog Number	CDC-15703-P1A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "patient was coding, there was a lot of activity in the room, and they were turning the patient and the catheter slipped right out of the hub and was laying on the floor." new vascular access obtained.No medical intervention required.The patients current condition is reported as "fine".No patient injury or consequence.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The customer report of a catheter migrated could not be confirmed through complaint investigation of the returned sample.The customer returned one clamp fastener and clamp catheter for evaluation.Signs-of-use were observed on the returned components.The catheter was not returned.Visual inspection of the clamp catheter and clamp fastener revealed no obvious defects or anomalies.The returned clamp catheter and clamp fastener met all relevant dimensional and functional requirements.Dimensional and functional inspection of the catheter could not be performed as it was not returned for analysis.The instructions-for-use (ifu) provided with the kit warns the user, "minimize catheter manipulation throughout procedure to maintain proper catheter tip position.Secure catheter clamp and fastener as a unit to patient by using either catheter stabilization device, stapling, or suturing.Both catheter clamp and fastener need to be secured to reduce risk of catheter migration." a device history record review was performed based on sales history with no relevant findings.Based on these circumstances, the probable root cause could not be determined without the complete sample returned for analysis.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "patient was coding, there was a lot of activity in the room, and they were turning the patient and the catheter sliped right out of the hub and was laying on the floor." new vascular access obtained.No medical intervention required.The patients current condition is reported as "fine".No patient injury or consequence.

• Brand Name: ARROW MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAP
• 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: 18778929
• Report Number: 9680794-2024-00239
• Device Sequence Number: 12894558
• Product Code: FOZ
• UDI-Device Identifier: 10801902116793
• UDI-Public: 10801902116793
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2024

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: CDC-15703-P1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 03/21/2024
• 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