MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH KIT: 20 GA X 1-3/4"; CATHETER PERCUTANEOUS

Catalog Number	AK-04020-SPC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported: "after the registered nurse (rn) removed an arterial line from the right wrist, he noted a piece of the catheter tip was broken off.Foreign body viewed on ultrasound.Patient was taken to the surgical operating room, and the foreign body was removed successfully.The tip was noted to be 3.5 cm in length and 0.2 cm in diameter.The patient was discharged and had no harm or injury.".
Event or Problem Description
It was reported: "after the registered nurse (rn) removed an arterial line from the right wrist, he noted a piece of the catheter tip was broken off.Foreign body viewed on ultrasound.Patient was taken to the surgical operating room, and the foreign body was removed successfully.The tip was noted to be 3.5 cm in length and 0.2 cm in diameter.The patient was discharged and had no harm or injury".
Additional Manufacturer Narrative
(b)(4).Corrected data: section g.2.-report source corrected to 'other' - medwatch.The customer returned one portion on an arterial catheter body for evaluation.Clear signs of use were identified as there was disco loration on the catheter body.Visual analysis revealed that the catheter body was separated towards the proximal end.Microscopic examination confirmed the damage and revealed that the point of separation was angled, smooth, and showed no evidence of stretching.This damage is consistent with contact with sharps during use (i.E.Needle bevel) during use.The separated catheter body piece measured 1.441", which is not within the specification limits of 1.541"-1.581" per catheter product drawing.This confirms that not all of the separated catheter was returned for investigation.The catheter body outer diameter measured 0.044", which is within the specification limits of 0.044"-0.047" per the catheter extrusion product drawing.The catheter body inner diameter at the point of separation measured 0.033", which is within the specification limits of 0.031"-0.034" per the catheter extrusion product drawing.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "precaution: once the catheter is partially threaded off the needle, do not attempt to advance needle into catheter again - this may cause catheter damage." the report of arterial catheter separated during use was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the catheter body was severed towards the proximal end.The appearance of the point of separation was consistent with damage resulting from the catheter coming into contact with the needle bevel during use.The ifu provided with the finished kit warns the user, "precaution: once the catheter is partially threaded off the needle, do not attempt to advance needle into catheter again - this may cause catheter damage.".Based on the available information and the sample received, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW RA CATH KIT: 20 GA X 1-3/4"
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20893935
• Report Number: 9680794-2024-01233
• Device Sequence Number: 8933974
• Product Code: DQY
• UDI-Device Identifier: 10801902121551
• UDI-Public: (01)10801902121551(11)240409(17)260430(10)33F24C0729(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K021120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: AK-04020-SPC
• Device Lot Number: 33F24C0729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic