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

Catalog Number	CS-24703-E
Medical Device Problem Codes	Dull, Blunt (2407); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the puncture needle inside the packaging was blunted, making it impossible to successfully puncture the patient." returned needle was found to be bent.
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened cvc kit.The 18ga introducer needle will be analyzed as part of this complaint investigation.Signs-of-use were observed inside the needle hub.Visual inspection of the needle revealed a slight bend adjacent to the needle hub.Scratch marks were visible along the length of the inside the needle guard.No defects or anomalies were observed on any of the other kit components.No abnormal bending/damage was observed on the tray.The bend on the cannula measured 2mm from the needle hub.The needle cannula outer diameter measured 0.0495", which is within the specification of the cannula product drawing.The cannula inner diameter at the distal and proximal openings measured 0.041", which is within the specification of the cannula product drawing.A lab inventory guide wire measured 0.0315", was inserted into the introducer needle.Despite the bending, the guide wire was able to pass with little to no resistance.Performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".The manufacturing facility was contacted as part of this complaint i nvestigation.They indicated that needles of this type are 100% inspected for such damage.The cannula product drawing was reviewed as part of this complaint.The ifu provided with the kit informs the user, "do not alter the catheter, guidewire or any other kit/set component during insertion, use or removal".The report of a bent needle was confirmed through complaint investigation of the returned sample.Visual analysis revealed a slight bend adjacent to the needle hub.Despite the damage, the sample met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report that the bending was detected "during use" and the comments from manufacturing, the root cause cannot be determined as is unknown if the failure occurred before or after the customer handled.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "the puncture needle inside the packaging was blunted, making it impossible to successfully puncture the patient." returned needle was found to be bent.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20265670
• Report Number: 3006425876-2024-00929
• Device Sequence Number: 12811054
• Product Code: FOZ
• UDI-Device Identifier: 00801902102287
• UDI-Public: (01)00801902102287(11)230428(17)250331(10)71F23D2853(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K900263
• 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): 08/28/2024

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: 03/31/2025
• Device Catalogue Number: CS-24703-E
• Device Lot Number: 71F23D2853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown