MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN032560
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported "the peel away does not snap and split.One of the tabs will snap off entirely leaving us with no way to peel the sheath apart.".It was reported there was a delay in theapy due to the time to remove and replace the catheter.No patient harm was reported.
Additional Manufacturer Narrative
(b)(4).The actual sample was not returned; however, the customer provided seven photos for evaluation.Visual inspection of the photos confirmed the peel-away sheath did not fully peel correctly.The edges appeared rippled.However, a full visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit instructs the user, "sharply snap tabs of valve housing in a plane, perpendicular to long axis of sheath to split valve and split sheath apart while withdrawing from vessel." the customer report of a damaged peel-away sheath was confirmed by visual inspection of the customer supplied photo.However, 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 probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Customer reported "the peel away does not snap and split.One of the tabs will snap off entirely leaving us with no way to peel the sheath apart." it was reported there was a delay in theapy due to the time to remove and replace the catheter.No patient harm was reported.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11859826
• Report Number: 9680794-2021-00239
• Device Sequence Number: 11749574
• Product Code: MSD
• UDI-Device Identifier: 00801902095916
• UDI-Public: 00801902095916
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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: No Information
• Device Expiration Date: 09/30/2023
• Device Model Number: IPN032560
• Device Catalogue Number: AC-15232-X
• Device Lot Number: 13F20H0741
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1