MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET: 2-LUMEN 5 FR X 19-1/2" (50 CM); CATHETER, INTRAVASCULAR, THER

Model Number	IPN033360
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the peelaway is broken" during use while trying to pass the catheter after dilation.The device was completely removed and a new catheter and sheath were used.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer report of a damaged peel-away sheath body was confirmed by visual inspection of the customer supplied photo.However, full complaint verification testing could not be performed as no sample was returned for analysis.The ifu provided with the kit informs the user, "grasping near skin, advance peel-away sheath/dilator assembly over guidewire with slight twisting motion to a depth sufficient to enter vessel".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
It was reported "the peelaway is broken" during use while trying to pass the catheter after dilation.The device was completely removed and a new catheter and sheath were used.No patient harm was reported.The patient's condition is reported as fine.

• Brand Name: ARROW PICC SET: 2-LUMEN 5 FR X 19-1/2" (50 CM)
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17324666
• Report Number: 9680794-2023-00518
• Device Sequence Number: 12342126
• Product Code: LJS
• UDI-Device Identifier: 10801902095371
• UDI-Public: 10801902095371
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K042126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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
• Device Expiration Date: 11/30/2024
• Device Model Number: IPN033360
• Device Catalogue Number: PR-05052
• Device Lot Number: 14F22M0010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown