MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 50 CM; INTRODUCER, CATHETER

Model Number	IPN037304
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the tab broke off the peel-away sheath during removal.No patient harm reported.The patient's condition is reported as fine.
Event or Problem Description
It was reported the tab broke off the peel-away sheath during removal.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one peel-away sheath for evaluation.Signs of use were observed on the peel-away sheath.Visual inspection of the sample revealed the sheath is fully split along its score lines.One of the sheath tabs is broken off at the level of the juncture hub.The separation point was jagged.Some molding of the sheath was still visible in the separated tab.The sheath body length measured 2 3/4" which is within the specifications of 2 5/8" - 2 7/8" per peel-away sheath product drawing.Functional inspection could not be performed on the peel-away sheath due to the damage.A device history record review was performed with no relevant findings.The instructions for use (ifu) provided with this kit instructs the user , "thread catheter distal lumen over guidewire and advance catheter over guidewire through sheath into vessel.Grasp tabs of peel-away sheath and pull apart, away from catheter, while withdrawing from vessel until sheath splits down its entire length.Do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator or tissue dilator as this can lead to vessel perforation and bleeding.".The customer report of a peel-away sheath tab broken in use was confirmed through complaint investigation of the returned sample.Visual inspection revealed the peel-away sheath had separated during use along its score lines, and one of the peel-away sheath tabs had broken off at the level of the juncture hub.Some molding was still visible in the separated tab.Manufacturing engineers were contacted and they indicated this is likely an error during the molding process.Based on these circumstances, manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 50 CM
• Common Device Name: INTRODUCER, CATHETER
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14577522
• Report Number: 9680794-2022-00354
• Device Sequence Number: 5041523
• Product Code: DYB
• UDI-Device Identifier: 60801902120740
• UDI-Public: 60801902120740
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2022

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: 03/31/2023
• Device Model Number: IPN037304
• Device Catalogue Number: CDC-45041-VPS2
• Device Lot Number: 13F21K1010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• 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
• Patient Sex: Unknown