MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS SET: 2-LUMEN 14 FR X 25 CM; CATHETER HEMODIALYTSIS NON IMP

Model Number	IPN919781
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: on (b)(6) 2023, during a plasmapheresis session, the team noticed that the catheter inserted into the patient the previous week had slipped out of its securing ring and had come out of the patient's leg.Another catheter was inserted to continue the plasmapheresis.Device discarded.Additional information: the patient lost very little blood as the issue was identified immediately and they did not need a transfusion.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer provided two photos for analysis.The complaint of a catheter migrated was confirmed by the photos.The images show that the catheter had separated from the juncture hub suture wings during use.However, a complete visual inspection 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 secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations.Indwelling catheters should be routinely inspected for desired flow rate, security of dressing, correct catheter position , and for secure luer-lock connection.Use centimeter markings to identify if the catheter position has changed." the customer report of a migrated catheter was confirmed by visual inspection of the customer supplied photos.The photos show that the catheter had separated from the juncture hub suture wings during use , which likely resulted in the catheter migration reported by the customer.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing related issue.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.
Event or Problem Description
It was reported that: on (b)(6) 2023, during a plasmapheresis session, the team noticed that the catheter inserted into the patient the previous week had slipped out of its securing ring and had come out of the patient's leg.Another catheter was inserted to continue the plasmapheresis.Device discarded.Additional information: the patient lost very little blood as the issue was identified immediately and they did not need a transfusion.
Additional Manufacturer Narrative
Qn# (b)(4).Udi related data quality updates only.Section d.4.-(udi)# corrected to (b)(4).The customer provided two photos for analysis.The complaint of a catheter migrated was confirmed by the photos.The images show that the catheter had separated from the juncture hub suture wings during use.However, a complete visual inspection 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 secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations.Indwelling catheters should be routinely inspected for desired flow rate, security of dressing, correct catheter position, and for secure luer-lock connection.Use centimeter markings to identify if the catheter position has changed." the customer report of a migrated catheter was confirmed by visual inspection of the customer supplied photos.The photos show that the catheter had separated from the juncture hub suture wings during use, which likely resulted in the catheter migration reported by the customer.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing related issue.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.
Event or Problem Description
It was reported that: on (b)(6) 2023, during a plasmapheresis session, the team noticed that the catheter inserted into the patient the previous week had slipped out of its securing ring and had come out of the patient's leg.Another catheter was inserted to continue the plasmapheresis.Device discarded.Additional information: the patient lost very little blood as the issue was identified immediately and they did not need a transfusion.

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 14 FR X 25 CM
• Common Device Name: CATHETER HEMODIALYTSIS NON IMP
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17858936
• Report Number: 3006425876-2023-00947
• Device Sequence Number: 20266238
• Product Code: MPB
• UDI-Device Identifier: 10801902100235
• UDI-Public: (01)10801902100235(11)230511(17)250331(10)71F23D2892(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K993933
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: IPN919781
• Device Catalogue Number: CS-26142-F
• Device Lot Number: 71F23D2892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 10/26/2023; Not provided
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 10/27/2023; 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2023
• 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.; NOT REPORTED.
• Patient Sex: Female