MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM; CATHETER INTRAVSCULAR THERAPEU

Catalog Number	CDC-45552-VPS2
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: peel-away sheath separated at one of the white tabs.
Additional Manufacturer Narrative
(b)(4).The report of a peel-away sheath tab breaking off was confirmed through complaint investigation of the returned sample.The customer returned one peel-away sheath for analysis.Signs of use in the form of biological material were observed.Visual analysis revealed that one tab of the peel-away sheath was separated adjacent to the hub.It was noted that both the seam lines were completely split.Microscopic examination confirmed the damage.The peel-away length measured 2 13/16" via calibrated ruler, which was within the specification limits of 2 5/8" - 2 7/8" per the catheter peel-away product drawing.The sheath outer/inner diameter could not be accurately measured due to the severity of the damage.The ifu provided with the kit informs the user, "check peel-away sheath placement by holding sheath in place, twisting dilator hub counterclockwise to release dilator hub from sheath hub, withdraw guidewire and dilator sufficiently to allow blood flow".A device history record review was performed, and no relevant findings were identified.Based on these circumstances and comments from the manufacturing unit, manufacturing process likely caused or contributed to this issue.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this iss ue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: peel-away sheath separated at one of the white tabs.

• Brand Name: AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM
• Common Device Name: CATHETER INTRAVSCULAR THERAPEU
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18473708
• Report Number: 1036844-2024-00002
• Device Sequence Number: 6885597
• Product Code: LJS
• UDI-Device Identifier: 30801902120794
• UDI-Public: 30801902120794
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup

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: 11/30/2024
• Device Catalogue Number: CDC-45552-VPS2
• Device Lot Number: 33F23G0461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2023
• 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
• Patient Sex: Unknown