MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CANNON II PLUS REPLACEMENT HUB SET; CATHETER HEMODIALYTSIS NON IMP

Catalog Number	CAR-02800
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported the luer hub was found cracked during hemodialysis.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one connector assembly for evaluation.Signs of use in the form of adhesive residue was observed on the juncture hub.Visual analysis revealed the red (arterial) luer hub contained one large crack.This damage is consistent with repeated tightening on the luer.The returned sample was functionally tested in accordance with the instructions-for-use (ifu).The ifu provided with this kit instructs the user, "flush catheter thoroughly with normal saline to remove residual blood, post-treatment and before instilling heparin".When the arterial luer was flushed , significant leaking was observed at the location of the crack.No leaks were observed when the venous luer was flushed.A manual tug test confirmed that 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 the kit informs 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 one large crack.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 use error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported the luer hub was found cracked during hemodialysis.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW CANNON II PLUS REPLACEMENT HUB SET
• Common Device Name: CATHETER HEMODIALYTSIS NON IMP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12350513
• Report Number: 9680794-2021-00416
• Device Sequence Number: 4333946
• Product Code: MPB
• UDI-Device Identifier: 30801902096129
• UDI-Public: 30801902096129
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993933
• 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): 08/05/2021

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: 03/31/2023
• Device Catalogue Number: CAR-02800
• Device Lot Number: 13F20D0293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/22/2021
• 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: HEMODIALYSIS; HEMODIALYSIS; HEMODIALYSIS