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

Catalog Number	RA-04020-SP
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "during insertion the red top cracked".As a result, another device was used.No patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "during insertion the red top cracked".As a result, another device was used.No patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4) the actual device was not returned; however, the customer provided one photo for analysis.The complaint of needle protection cap separating from the base was able to be confirmed by the photo.The photo shows the needle protection cap (a-04020-028a) separated from the needle protection base (a-04020-027a).The needle cap is meant to lock onto the needle based and should not deploy off and remain attached to the catheter hub.However, a complete visual inspection to evaluate the potential cause of the damage could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with this kit warns the user, "do not attempt to override or defeat the locking needle protection mechanism.Precaution: do not grasp or contact needle protection assembly.The needle protection assembly will remain attached to proximal end of catheter hub until needlepoint passes through assembly and activates during withdrawal." the customer report of needle protection cap separating from the base was confirmed by visual inspection of the customer supplied photo.The photo shows the needle protection cap separated from the needle protection base.The needle cap is intended to lock onto the needle based and should not deploy off and remain attached to the catheter hub.Based on the photo the defect is confirmed, however, full complaint verification testing could not be performed to evaluate the potential cause of the damage as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW RA CATH SET: 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: 19014114
• Report Number: 9680794-2024-00303
• Device Sequence Number: 12802530
• Product Code: DQY
• UDI-Device Identifier: 00801902027528
• UDI-Public: 00801902027528
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K021120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2024

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: RA-04020-SP
• Device Lot Number: 14F23F0138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2023
• 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