MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AM PICC SET 1-L: 4.5 FR X 50 CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	PR-45041-HP
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported 'the patient has a unilumen picc line in the right upper limb for the administration of treatment.During the disinfection of the catheter port, the port broke, and the blue safety clamp detached, the rest of the catheter remained intact, allowing the venoclysis equipment to be connected, and therapy was subsequently started'.The patient was fine and had no harm or injury.
Event or Problem Description
It was reported 'the patient has a unilumen picc line in the right upper limb for the administration of treatment.During the disinfection of the catheter port, the port broke, and the blue safety clamp detached, the rest of the catheter remained intact, allowing the venoclysis equipment to be connected, and therapy was subsequently started'.The patient was fine and had no harm or injury.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed, and a finding was identified.A non-conformance was initiated for batch 13p22k0430 to address the issue of a damaged packaging container; however, as the device was not returned for analysis, it cannot be verified if this is the same issue being addressed in this complaint.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested".The ifu also states, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations".The ifu also states, "do not use if package is damaged".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.

• Brand Name: ARROW AM PICC SET 1-L: 4.5 FR X 50 CM
• 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: 20976129
• Report Number: 9680794-2024-01250
• Device Sequence Number: 3955384
• Product Code: LJS
• UDI-Device Identifier: 10801902095715
• UDI-Public: (01)10801902095715(11)230517(17)250425(10)14F23E0115(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K112896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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: 04/25/2025
• Device Catalogue Number: PR-45041-HP
• Device Lot Number: 14F23E0115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• 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: N/A.; N/A.
• Patient Sex: Male