MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PEDIATRIC JUGULAR SET: 20 GA X 12 CM; CATHETER PERCUTANEOUS

Catalog Number	ES-04150
Medical Device Problem Codes	Difficult to Insert (1316); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "while checking the catheter (prior to use on a patient) under sterile conditions, it was observed that the wire did not pass through the needle and gets stuck." the operator changed to a new kit.
Additional Manufacturer Narrative
(b)(4).The customer provided two images showing an opened pediatric cvc kit and two guide wires inserted through the introducer needles.Visual analysis could not confirm swg/needle resistance based on the photos.The customer also returned one guide wire inserted through the 20ga introducer needle.No obvious signs of use were observed.Visual analysis revealed two kinks on the guide wire.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.The kinking on the guide wire measured 187mm and 350mm from the proximal weld.The guide wire lengths both measured 13 15/16", which are within the specification limits of 13 25/32"-14" per the guide wire product drawing.The guide wire outer diameters both measured 0.0241", which is within the specification limits of 0.0240"-0.0250" per the guide wire product drawing.The inner diameter of the introducer needles at the distal and proximal ends measured 0.027" , which is within the specification limits of 0.027"-0.0285" per the cannula product drawing.The guide wire was removed from the introducer needle and were re-inserted back through the hub end.All functional sections of the guide wire passed with no resistance; however , resistance was encountered as the location of the kinks.Performed per ifu statement, "using the two-piece arrow advancer , advance spring-wire guide through guide wire introducer needle or catheter into vein".A manual tug test on all guide wires revealed that the welds are secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "due to the fragile nature of the spring-wire guide contained in this product, inspect 'j'-tip for damage prior to insertion".The ifu also states, "do not cut spring-wire guide to alter length.Do not withdraw spring wire guide against needle bevel to minimize the risk of possible severing or damaging of spring-wire guide." the report of guide wire/needle resistance was confirmed through complaint investigation.The returned guide wire was observed to be kinked in two locations.This kinking created significant resistance when passing through the cannula.Despite the damage, the guide wire and introducer needle met all relevant dimensional requirements.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PEDIATRIC JUGULAR SET: 20 GA X 12 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20747009
• Report Number: 9680794-2024-01124
• Device Sequence Number: 8362583
• Product Code: DQY
• UDI-Device Identifier: 00801902100535
• UDI-Public: (01)00801902100535(11)200906(17)241231(10)14F20H0035(21)
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K810962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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 Expiration Date: 12/31/2024
• Device Catalogue Number: ES-04150
• Device Lot Number: 14F20H0035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2020
• 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
• Patient Sex: Unknown