MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 2L 5FRX55CM W/80CM HYDRO NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-35552-HPHNM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "called by cpa from northern hospital about picc "fracture" hub has fallen off the picc whilst in patient on ward." the device was removed and replaced.There was no medical intervention required.No patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of a separated extension line at the luer hub was able to be confirmed by the photo as it revealed separation of the distal extension line luer hub from the extension line.However, without the sample returned for analysis, a complete visual inspection could not be performed.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage." 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.".Without the device to evaluate, 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 "called by cpa from northern hospital about picc "fracture" hub has fallen off the picc whilst in patient on ward." the device was removed and replaced.There was no medical intervention required.No patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The photo shows a separation of the distal extension line luer hub from the extension line.The customer also returned one, distal extension line luer hub for analysis.The rest of the catheter was not returned.Signs of use were observed.Visual and microscopic analysis confirmed a portion of the extension line was still molded within the separated luer hub.This damage is consistent with a manufacturing molding defect.The inner diameter of the distal extension line measured 0.059", which is within the specification limits of 0.055"-0.059" per distal extension line extrusion product drawing.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "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 report of extension line/luer hub separation was confirmed through complaint investigation of the returned sample.Visual and microscopic analysis revealed the distal extension line was separated from the luer hub.A portion of the extension line was still molded within the separated luer hub, which is consistent with a manufacturing molding defect.Based on the appearance of the damage, manufacturing caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend complaints of this nature.
Event or Problem Description
It was reported "called by cpa from northern hospital about picc "fracture" hub has fallen off the picc whilst in patient on ward." the device was removed and replaced.There was no medical intervention required.No patient harm or injury.The patient's current condition is reported as "fine".

• Brand Name: ARROW PI PICC 2L 5FRX55CM W/80CM HYDRO NIT SWG
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• 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: 20694559
• Report Number: 9680794-2024-01104
• Device Sequence Number: 17106344
• Product Code: LJS
• UDI-Device Identifier: 00801902095619
• UDI-Public: (01)00801902095619(11)240401(17)260228(10)33F24B0723(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2024

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: 02/28/2026
• Device Catalogue Number: PR-35552-HPHNM
• Device Lot Number: 33F24B0723
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 12/10/2024; 01/03/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/16/2024; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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: Unknown