MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC KIT: 4 FR X 50 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	EU-05041-HPMSB
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "at the time of opening the kit, the guide wire was bent".There was no patient involvement.No patient harm or injury.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The photo shows a kinked portion of a guide wire exposed out of the protective tubing.The customer returned one guide wire in its protective tubing for evaluation.No signs of use were observed on the guide.Visual inspection of the guide wire revealed several small kinks near the distal end.The kinks were located in an area of the guide wire that is not covered by the protective tubing.Visual inspection of the tray could not be performed as it was not returned for analysis.The kinks in the guide wire were located 6mm and 12mm from the distal end.The guide wire total length measured 334mm which is within the specifications of 327-339.8mm per product drawing.The guide wire outer diameter measured 0.446mm which is within the specifications of 0.432-0.457mm per product drawing.Functional inspection of the guide wire was performed per the instructions-for-use (ifu) provided with the kit which states, "advance guidewire into introducer needle." the undamaged portions of the guide wire were threaded through a lab inventory introducer needle with no resistance.The manufacturing facility was contacted regarding this defect.They indicated that the guide wires are 100% inspected during assembly before being placed in the protective tubing.No inspections are performed on the guide wire assembly during the final packaging of the kit.Without the rest of the kit returned, it cannot be determined if the observed damage occurred before or after the final packaging process.A device history record review was performed with no relevant findings.The instructions-for-use (ifu) provided with the kit warns the user , "do not use if package is damaged.".The customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual inspection revealed several kinks on the guide wire.These kinks are located in an area that it is not protected by the tubing assembly during packaging, shipping, and storage.The returned guide wire met all relevant dimensional/functional requirements, and a device history record review was performed with no relevant findings.Based on the available information, the comments from manufacturing, and without the complete sample returned for analysis, it is unknown if the kinking occurred before or after the final packaging process.Therefore, the probable root cause could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.Corrected data: section d.4.- unique identifier (udi) # corrected from (b)(4).
Event or Problem Description
It was reported "at the time of opening the kit, the guide wire was bent".There was no patient involvement.No patient harm or injury.

• Brand Name: ARROW PI PICC KIT: 4 FR X 50 CM
• 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: 19444883
• Report Number: 9680794-2024-00574
• Device Sequence Number: 8567854
• Product Code: LJS
• UDI-Device Identifier: 10801902094763
• UDI-Public: 10801902094763
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K061289
• 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,Followup
• Report Date (Section B): 05/16/2024

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: 07/31/2025
• Device Catalogue Number: EU-05041-HPMSB
• Device Lot Number: 33F23J0247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 06/02/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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