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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the white handle on the peelaway sheath broke off on one side just above where the body of the sheath attaches to the handles.The clinician was able to use a hemostat and peel away one side of the sheath to get it off the indwelling line.The picc was inserted without incident after removing the broken peelaway.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns 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 based on a potential lot from sales history, and no relevant findings were identified.Without the device to evaluate, 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.
Event or Problem Description
It was reported the white handle on the peelaway sheath broke off on one side just above where the body of the sheath attaches to the handles.The clinician was able to use a hemostat and peel away one side of the sheath to get it off the indwelling line.The picc was inserted without incident after removing the broken peelaway.No patient harm reported.The patient's condition is reported as fine.

• 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: 17844065
• Report Number: 9680794-2023-00711
• Device Sequence Number: 4401910
• 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): 09/05/2023

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 Catalogue Number: ASK-45541-CRMC1
• Device Lot Number: 14F23E0261
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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