MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI LUMEN PI CVC KIT: 3L 7 FR; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	ASK-45703-SL1
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "threading wire through needle wouldn't pass, pulled wire out and discovered it was frayed".No medical intervention required.No patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The report that the guide wire was unravelled was confirmed through examination of the returned sample.The customer returned one guide wire for evaluation and the 18ga introducer needle was not returned.Visual examination revealed the guide wire was unravelled from the distal weld.The distal end of the core wire was broken and protruding out of the coil wire.Dimensional inspection and a device history record review based on a potential lot from sales history did not reveal any evidence of a manufacturing related issue.Functional inspection of the guide wire could not be performed for this complaint investigation due to the damage to the returned guide wire.The instructions-for-use (ifu) provided with this product warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained, and further consultation requested.Do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specif ication is higher than the bs en iso standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error likely contributed to this event, however, the probable cause of guide wire and needle resistance could not be determined based upon the information provided and without the needle being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "threading wire through needle wouldn't pass, pulled wire out and discovered it was frayed".No medical intervention required.No patient harm or injury.The patient's current condition is reported as "fine".

• Brand Name: ARROW MULTI LUMEN PI CVC KIT: 3L 7 FR
• 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: 18968144
• Report Number: 9680794-2024-00289
• Device Sequence Number: 17717030
• Product Code: FOZ
• UDI-Device Identifier: 10801902202366
• UDI-Public: 10801902202366
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2024

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-45703-SL1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/04/2024
• 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