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

Model Number	IPN033136
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure, the physician could not enter the guidewire into the raulerson syringe.A new kit was opened to finish the procedure.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The report of a kinked guide wire was confirmed through complaint investigation of the returned sample.The customer returned an opened pediatric jugular set including one guide wire in its advancer and a 20ga introducer needle for analysis.The arrow raulerson syringe (ars) was not returned for analysis.Signs-of-use in the form of biological material were observed on the guide wire assembly.Visual analysis revealed that the guide wire had two kinks towards the distal j-bend.There was a build of biological material in the form of dried blood in the straightener tube.Microscopic examination confirmed the kinking.Both welds appeared full and intact.Visual inspection of the ars could not be performed as it was not returned for analysis.The kinks on the guide wire measured 42mm and 52mm from the distal tip and the guide wire length measured 355mm via calibrated ruler, which was within the specification limits of 350.0mm-355.6mm per the guide wire product drawing.The guide wire outer diameter measured 0.0242" via calibrated micrometer, which was within the specification limits of 0.0240" - 0.0250" per the guide wire product drawing.Functional inspection was performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".The dried blood in the straightener tube was flushed out and removed.The guide wire was inserted through a laboratory inventory ars and the returned 20ga introducer needle.The guide wire was able to pass with minimal resistance.Functional inspection of the actual ars could not be performed as it was not returned for analysis.A manual tug test confirmed that the distal and proximal welds were secure and intact.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The ifu also states, "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" and "warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." a device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, the root cause could not be determined since there was no ars provided within the kit, and the reported ars was not returned.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported during the procedure, the physician could not enter the guidewire into the raulerson syringe.A new kit was opened to finish the procedure.No patient harm was reported.The patient's condition is reported as fine.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17310969
• Report Number: 9680794-2023-00542
• Device Sequence Number: 7214083
• Product Code: DQY
• UDI-Device Identifier: 00801902100535
• UDI-Public: 00801902100535
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K810962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: 04/30/2026
• Device Model Number: IPN033136
• Device Catalogue Number: ES-04150
• Device Lot Number: 14F21J0093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2021
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown