MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM BP; CATHETER, INTRAVASCULAR, THERA

Model Number	IPN924166
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while peeling the sheath, the inserter tore off one of the white wings.The patient was not harmed , and the inserter was able to pull the remaining sheath out of the patient's skin and proceed with insertion.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported while peeling the sheath, the inserter tore off one of the white wings.The patient was not harmed, and the inserter was able to pull the remaining sheath out of the patient's skin and proceed with insertion.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one peel-away sheath for investigation.Signs of use in the form of biological material were observed on the sheath.Visual examination revealed one sheath tab was separated from the sheath body.A portion of the sheath body remained within the hub.The separation points appeared stretched and jagged.It was observed that the sheath did not fully tear along the score lines.One blue score line was partially separated/torn.The total length of the sheath body measured to be 2 7/8" which is within the specifications of 2 5/8"-2 7/8" per product drawing.The sheath outer diameter measured 0.09775", which is within the specification limits of 0.096"-0.102" per product drawing.The sheath inner diameter at the tip measured 0.078", which is within the specifications of 0.077"-0.078" per product drawing.A manual tug test confirmed the remaining tab was fully secured to the sheath body.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit instructs the user, "grasp tabs of peel-away sheath and pull away from the catheter, while withdrawing from vessel until sheath splits down its entire length." the report of a peel-away sheath tearing incorrectly was confirmed through complaint investigation of the returned sample.Visual examination revealed one sheath tab was separated from the sheath extrusion.The sheath met all relevant dimensional requirements.The appearance of the defect seems consistent with damage that occurred during the manufacturing process.Based on the customer report and the sample received, manufacturing caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM BP
• Common Device Name: CATHETER, INTRAVASCULAR, THERA
• 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: 16376521
• Report Number: 9680794-2023-00068
• Device Sequence Number: 6201199
• Product Code: LJS
• UDI-Device Identifier: 10801902208702
• UDI-Public: 10801902208702
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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: 11/30/2023
• Device Model Number: IPN924166
• Device Catalogue Number: DLX-45552-CURVB
• Device Lot Number: 13F22K0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• 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