MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN033035
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
The red luer hub was found cracked during use on patient.No patient harm reported.No report of a required intervention.The patient's condition is reported as fine.
Event or Problem Description
The red luer hub was found cracked during use on patient.No patient harm reported.No report of a required intervention.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one connector assembly for evaluation.The sample contained obvious signs of use in the form of biological material.Visual analysis revealed the red (arterial) luer hub contained two large cracks.This damage is consistent with repeated tightening on the luer.Water leaked from the cracks in the hub when flushed using a lab inventory syringe.A manual tug test confirmed both luer hubs were secure to their extension lines.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure." the customer report of a cracked luer hub was confirmed by complaint investigation of the returned sample.The arterial (red) luer hub contained two large cracks.The appearance of the crack is consistent with overtightening on the luer.A device history record review was performed with no relevant findings.Based on the customer report and the condition of the sample received, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11278354
• Report Number: 9680794-2021-00034
• Device Sequence Number: 3383275
• Product Code: MSD
• UDI-Device Identifier: 00801902043917
• UDI-Public: 00801902043917
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111117
• 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): 01/18/2021

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: 05/31/2023
• Device Model Number: IPN033035
• Device Catalogue Number: CS-15242-VSP
• Device Lot Number: 13F20F0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1