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

Model Number	IPN038336
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported that "as the icu patient was in need of dialysis, an acute haemodialysis catheter was placed (femoral placement).The catheter got placed correctly (the catheter functions properly) and the catheter got placed according to the ifu.When the nephrologist withdrew the swg, it was nevertheless kinked and disentangled." no patient harm reported.The patient's condition was reported as critical, unrelated to the device.The patient remained in icu and recovering at the time of this report.
Event or Problem Description
Customer reported that "as the icu patient was in need of dialysis, an acute haemodialysis catheter was placed (femoral placement).The catheter got placed correctly (the catheter functions properly) and the catheter got placed according to the ifu.When the nephrologist withdrew the swg, it was nevertheless kinked and disentangled." no patient harm reported.The patient's condition was reported as critical, unrelated to the device.The patient remained in icu and recovering at the time of this report.
Additional Manufacturer Narrative
Qn#(b)(4).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 complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11361193
• Report Number: 3006425876-2021-00152
• Device Sequence Number: 14375552
• Product Code: DQY
• UDI-Device Identifier: 10801902138887
• UDI-Public: 10801902138887
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K862056
• 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): 02/04/2021

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: Health Professional
• Device Expiration Date: 09/13/2025
• Device Model Number: IPN038336
• Device Catalogue Number: CS-15122-E
• Device Lot Number: 71F20K0342
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR