MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC OUS PI PICC KIT: 2-L 5.5FR X 50CM CG+; CATHETER,INTRAVASCULAR,THERAP

Model Number	IPN920811
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: the tabs of the peel away sheath broke off when attempting to peel the sheath away.There was no reported patient harm or consequence.The patient was reported as fine.
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and three relevant findings were identified.Non-conformances were initiated to address the issue of a defective peel-away sheath.Despite this, it cannot be confirmed if the failures addressed in these past non-conformances is the same failure reported by the customer without a sample returned for evaluation.Without the device returned, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that: the tabs of the peel away sheath broke off when attempting to peel the sheath away.There was no reported patient harm or consequence.The patient was reported as fine.
Event or Problem Description
It was reported that: the tabs of the peel away sheath broke off when attempting to peel the sheath away.There was no reported patient harm or consequence.The patient was reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one peel-away sheath for analysis.Signs of use in the form of biological material was observed.Visual analysis revealed that one peel away sheath extrusion was separated directly adjacent to the tab.A small portion of the extrusion was torn incorrectly starting from the location of the tab.A piece of the tab was also observed to be separated.Remains of the extrusion was still within the separated tab.The other tab was intact.It was also noted that the sheath was torn completely down both score lines.Damage to the sheath tip was also noted, however, the customer did not report this damage in the customer event description.A device history record review was performed and potentially relevant findings were identified.Non-conformances were created for material eb-01052-002 with batch 34c22c0032 regarding peel-away sheath tears incorrectly and peel-away sheath body damaged.The report of a broken peel away sheath tab was confirmed through complaint investigation.Visual analysis revealed that the sheath extrusion broke off at the location of the tab.A portion of the sheath extrusion was also observed to be torn incorrectly beyond the hub.Based on the customer report, the sample received, and the comments from r & d, 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: OUS PI PICC KIT: 2-L 5.5FR X 50CM CG+
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 18083891
• Report Number: 9680794-2023-00823
• Device Sequence Number: 18065499
• Product Code: LJS
• UDI-Device Identifier: 30801902128240
• UDI-Public: 30801902128240
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K112896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2024
• Device Model Number: IPN920811
• Device Catalogue Number: CDA-45052-HPK1A
• Device Lot Number: 33F23B0854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 11/28/2023; 04/22/2024
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 12/04/2023; 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2023
• 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.; NOT REPORTED.
• Patient Sex: Female