MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM; CATHETER HEMODIALYTSIS NON IMP

Model Number	IPN919796
Medical Device Problem Codes	Device Slipped (1584); Detachment of Device or Device Component (2907); Infusion or Flow Problem (2964); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: the line was stitched in - it slipped through the holder, happened twice on 1 patient (2nd device associated to this complaint), there was a previous issue the week before, - unwell lady with high inotrope requirements leading to a delay in continuing her cvvhd - the line was promptly replaced.(associated to 2 other complaints tc# (b)(4) and tc# (b)(4)).The patient's condition did not deteriorate due to immediate replacement of line, the patient was not harmed.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Additional information received from account: the catheter was secured to the patient skin via a plastic holder which was sutured via 2 small holes to the patients skin.The catheter could rotate freely but it slipped out of the holder.The customer provided two photos for analysis.The complaint of catheter migration was able to be confirmed by the photos.The photos show the suture wing clip separated from the catheter body.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 apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." the customer report of catheter migrated was confirmed by visual inspection of the customer supplied photos.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.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: the line was stitched in it slipped through the holder, happened twice on 1 patient (2nd device associated to this complaint), there was a previous issue the week before, unwell lady with high inotrope requirements leading to a delay in continuing her cvvhd the line was promptly replaced.(associated to 2 other complaints (b)(4)).The patient's condition did not deteriorate due to immediate replacement of line, the patient was not harmed.
Additional Manufacturer Narrative
(b)(4).Udi related data quality updates only.Section d.4.-(udi)# corrected to (b)(4).Additional information received from account: the catheter was secured to the patient skin via a plastic holder which was sutured via 2 small holes to the patients skin.The catheter could rotate freely but it slipped out of the holder.The customer provided two photos for analysis.The complaint of catheter migration was able to be confirmed by the photos.The photos show the suture wing clip separated from the catheter body.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 apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." the customer report of catheter migrated was confirmed by visual inspection of the customer supplied photos.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.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: the line was stitched in - it slipped through the holder, happened twice on 1 patient (2nd device associated to this complaint), there was a previous issue the week before, - unwell lady with high inotrope requirements leading to a delay in continuing her cvvhd - the line was promptly replaced.(associated to 2 other complaints (b)(4)).The patient's condition did not deteriorate due to immediate replacement of line, the patient was not harmed.

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 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: 17956383
• Report Number: 3006425876-2023-00995
• Device Sequence Number: 5263821
• Product Code: MPB
• UDI-Device Identifier: 00801902100221
• UDI-Public: (01)00801902100221(11)230619(17)250413(10)71F23F0934(21)
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/25/2023

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: 04/13/2025
• Device Model Number: IPN919796
• Device Catalogue Number: CS-25142-F
• Device Lot Number: 71F23F0934
• 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: 09/25/2023
• Supplement Date Received by Manufacturer: 11/14/2023; Not provided
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/14/2023; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female