MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER HEMODIALYTSIS NON IMP

Model Number	IPN038320
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
It was reported the ars syringe was found leaking during patient puncture.No patient harm reported.The patient's condition is reported as fine.
Event or Problem Description
It was reported the ars syringe was found leaking during patient puncture.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn #(b)(4).The customer returned an opened kit containing various components including an arrow raulerson syringe (ars) and introducer needle for evaluation.Visual analysis revealed one large crack on the needle hub.Microscopic examination confirmed the defect.The returned needle was functionally tested in accordance with the instructions-for-use (ifu) provided with this kit.The ifu states, "insert introducer needle with attached arrow raulerson syringe into vein and aspirate." the returned introducer needle was connected to the returned ars syringe to functionally test.When the syringe and needle were used to aspirate, air bubbles entered the syringe body.When the syringe and needle were used to expel water, small droplets of water appeared from the cracks in the hub.The ars was also used to aspirate and purge water.No leaks were detected.The hub of the needle was tested with the male luer gage and was within the specified range.This indicates that the luer conforms to iso 594-1:1986.A device history record review was performed with one potentially relevant finding.A non-conformance was initiated for a needle cannula detachment from the hub.However, as this was not observed in the returned sample, this finding was not relevant.The reported complaint cracked needle hub was confirmed by a complaint investigation on the returned sample.The returned introducer needle containing one large crack on the hub.Further investigation of this issue is being conducted under a capa.The capa failure investigation indicates that the probable cause is design related.Corrective actions have not yet been implemented.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER HEMODIALYTSIS NON IMP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12348602
• Report Number: 3006425876-2021-00771
• Device Sequence Number: 5189802
• Product Code: MPB
• UDI-Device Identifier: 10801902139204
• UDI-Public: 10801902139204
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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: No Information
• Device Expiration Date: 06/16/2022
• Device Model Number: IPN038320
• Device Catalogue Number: CS-25122-F
• Device Lot Number: 71F20H1643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1