MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA VPS PICC KIT: 1L 4.5 FR X 55 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	ASK-45541-CRMC1
Medical Device Problem Codes	Break (1069); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the peel-away sheath did not peel correctly.The sheath peeled part way and then the white handles broke away from the rest of the sheath that was around the picc.The clinician was able to use a hemostat and peel-away one side of the sheath to get it off of the indwelling line.The picc was completed without incident after removing the broken peel-away.No patient harm reported.The patient's condition is reported as fine.
Event or Problem Description
It was reported the peel-away sheath did not peel correctly.The sheath peeled part way and then the white handles broke away from the rest of the sheath that was around the picc.The clinician was able to use a hemostat and peel-away one side of the sheath to get it off of the indwelling line.The picc was completed without incident after removing the broken peel-away.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The report of a peel-away tearing incorrectly was confirmed through complaint investigation of the returned sample.The customer provided one image and returned one peel-away sheath for analysis.Signs-of-use were observed.Visual analysis of the sheath revealed that the sheath tore incorrectly and separated.A portion of the proximal end of the peel-away extrusion was still moulded to the separated tab.Microscopic examination confirmed the damage and revealed that the point of separation was stretched and jagged.It was noted that one score line was completely split down the extrusion.The other blue score line was still attached from the location of the damage to the distal end.The length of the sheath body measured 2 7/8" via calibrated ruler, which was within the specification limits of 2 5/8"-2 7/8" per the sheath peel-away product drawing.Functional inspection could not be performed due to the damage.A manual tug test confirmed the remaining tab was fully secured to the sheath body.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to venospasm, vessel perforation, bleeding, or component damage".A device history record review was performed, and a relevant finding was identified for which further investigations were initiated.Based on the customer report and sample received, manufacturing likely caused or contributed to this event.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA VPS PICC KIT: 1L 4.5 FR X 55 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 17808705
• Report Number: 9680794-2023-00691
• Device Sequence Number: 12501172
• Product Code: LJS
• UDI-Device Identifier: 10801902213102
• UDI-Public: 10801902213102
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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: 11/30/2024
• Device Catalogue Number: ASK-45541-CRMC1
• Device Lot Number: 33F23D0641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• 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