MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 14 GA X 6IN (16 CM); CATHETER PERCUTANEOUS

Catalog Number	ES-04706
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "(b)(6) 2024, the doctor found the syringe/needle connection not secure during use on the patient." the patient was reported as fine.
Additional Manufacturer Narrative
(b)(4).The report of a syringe/needle connection not secure was not able to be confirmed through complaint investigation of the returned sample.The customer returned one, opened cvc kit including the arrow raulerson syringe (ars) for analysis.The 18ga introducer needle was not returned for analysis.No definite signs of use were observed.The ars met all relevant visual and functional requirements.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 cannot be determined at this time without the introducer needle also returned for analysis.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "22 apr 2024, the doctor found the syringe/needle connection not secure during use on the patient." the patient was reported as fine.

• Brand Name: CVC SET: 14 GA X 6IN (16 CM)
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19339605
• Report Number: 3006425876-2024-00485
• Device Sequence Number: 12597663
• Product Code: DQY
• UDI-Device Identifier: 00801902108418
• UDI-Public: 00801902108418
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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: 07/31/2026
• Device Catalogue Number: ES-04706
• Device Lot Number: 71F21H1432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• 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