MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 15 FR X 27 CM; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN055271
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
The complaint is reported as: there were clinical signs of infusion (leaks) under the skin at the level of the catheter after insertion.The issue was solved by applying compression because of suspicion of oedema and post-insertion hematoma.Nevertheless symptoms resumed 10 days later when the compression was stopped.The device was changed.It was reported there was no consequence for the patient after the device was changed.
Additional Manufacturer Narrative
(b)(4).The customer returned one 2-lumen hemodialysis catheter for investigation.Signs of use in the form of biological material were observed.Visual examination revealed the catheter body appears intentionally cut.No other damages or anomalies were observed.The total length of the returned catheter body measured 18 cm which indicates that at least 13.3 cm of the catheter body was not returned per product drawing.The returned sample was functionally tested in accordance with the instructions-for-use (ifu).The ifu provided with this kit instructs the user, "flush each lumen with sterile saline solution, to establish patency and prime lumen(s)".Both lumens were flushed using a water-filled lab inventory syringe.No leaks or blockages were detected.Both lumens were then connected to the leak tester and leak tested in accordance with bs en iso 10555-1 annex c that states "there shall be no liquid leakage in the form of a falling drop of water at 300-320 kpa (43.5-46.4 psi) for 30 sec when tested per bs en iso-10555-1 annex c." both lumens were pressurized to 300 kpa with the distal end of catheter occluded.The pressure was held for 30 sec and the catheter body was monitored for leaks.No leaks were detected.A device history record review was performed with no relevant findings.The ifu provided with this kit states "flush each lumen with sterile saline solution, to establish patency and prime lumen(s)".The customer report of a catheter leak was not able to be confirmed by complaint investigation of the returned sample.The catheter passed all functional testing.A device history record review was performed with no relevant findings.Based on the sample received, no problem was found on the catheter.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
The complaint is reported as: there were clinical signs of infusion (leaks) under the skin at the level of the catheter after insertion.The issue was solved by applying compression because of suspicion of oedema and post-insertion hematoma.Nevertheless symptoms resumed 10 days later when the compression was stopped.The device was changed.It was reported there was no consequence for the patient after the device was changed.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 27 CM
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12206290
• Report Number: 9680794-2021-00356
• Device Sequence Number: 14532579
• Product Code: MSD
• UDI-Device Identifier: 20801902156017
• UDI-Public: 20801902156017
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: 02/28/2023
• Device Model Number: IPN055271
• Device Catalogue Number: CS-15272-SFX
• Device Lot Number: 13F20B0459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED