MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER PERCUTANEOUS

Model Number	IPN918762
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: luer connection of the insertion cannula had a crack.Air but no liquid could be aspirated into the syringe.The issue was identified during use.2 punctures were made with the needle and the issue was noticed on the second puncture.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: luer connection of the insertion cannula had a crack.Air but no liquid could be aspirated into the syringe.The issue was identified during use.2 punctures were made with the needle and the issue was noticed on the second puncture.
Additional Manufacturer Narrative
Qn#(b)(4).The customer report of a cracked needle hub was confirmed through visual inspection of the returned sample.The returned needle met all relevant requirements, and a device history record review was performed with no findings relevant to this investigation.Based on these circumstances and the comments from r & d, the root cause of this complaint is design related.Teleflex has identified that this needle hub material is susceptible to cracking when placed under stress (i.E.Pressed onto a tapered luer fitting, sideloaded as the clinician attempts to locate a vessel, etc.) in the presence of liquid alcohol-based disinfectants.An investigation was fully implemented 23-aug-2023 using a new alcohol-resistant material to manufacture the needle hub.The manufacturing date for the needle hub involved with this complaint occurred prior to the investigation implementation date.Teleflex will continue to monitor and trend for reports of this nature.
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: luer connection of the insertion cannula had a crack.Air but no liquid could be aspirated into the syringe.The issue was identified during use.2 punctures were made with the needle and the issue was noticed on the second puncture.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 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: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18099920
• Report Number: 3006425876-2023-01049
• Device Sequence Number: 20334330
• Product Code: DQY
• UDI-Device Identifier: 00801902105318
• UDI-Public: (01)00801902105318(11)220923(17)261031(10)71F22J2611(21)
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: IPN918762
• Device Catalogue Number: CV-14703
• Device Lot Number: 71F22J2611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 11/21/2023; Not provided
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 11/22/2023; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2022
• 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; NOT REPORTED
• Patient Sex: Unknown