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

Model Number	IPN055267
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported when the physician removed the dilator, the end of the dilator broke and remained on the guide.Fortunately by removing the guide the broken part of the dilator could be removed also.No patient injury or consequence.
Additional Manufacturer Narrative
(b)(4).The customer returned one photo confirming the complaint of a damaged dilator tip.Visual inspection of the photo revealed the dilator tip had separated from the dilator body.The customer returned one merit medical dilator for evaluation.The sheath was not returned.Visual inspection of the photo confirmed the dilator tip was damaged.The dilator tip had completely separated from the body.The two sections of the dilator returned measured 0.3125" and 8.1875" - totaling 8.5" which is within specifications of 8.49-8.51" per sheath/dilator product drawing.The outer diameter of the dilator measured 0.21105" which is within specifications of 0.209-0.212" per sheath/dilator product drawing.The inner diameter at dilator tip measured 0.038" which is within specifications of 0.038-0.039" per sheath/dilator product drawing.The returned dilator was functionally tested with a lab inventory merit medical sheath per ifu which states, "insert tissue dilator into sheath until dilator cap folds over valve housing and secures dilator onto sheath assembly." the dilator was inserted into the sheath with no issues.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 use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage." the complaint of a damaged dilator tip was confirmed by a complaint investigation of the returned sample and the customer photo.The dilator tip was completely separated from the dilator body.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample returned, the root cause of this investigation is supplier related.A non-conformance request has been initiated to further investigate the separated dilator tip.
Event or Problem Description
It was reported when the physician removed the dilator, the end of the dilator broke and remained on the guide.Fortunately by removing the guide the broken part of the dilator could be removed also.No patient injury or consequence.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12493389
• Report Number: 9680794-2021-00463
• Device Sequence Number: 17173660
• Product Code: MSD
• UDI-Device Identifier: 10801902156065
• UDI-Public: 10801902156065
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141051
• 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): 09/01/2021

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: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: IPN055267
• Device Catalogue Number: CS-15192-VFE
• Device Lot Number: 13F20G0621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 09/18/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1