MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CG+ PICC SET: 3L 6FR X 55CM W/130CM SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-45563-HPHNL
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the proximal part of the catheter has a small hole that caused leaking.The leakage happened right after the catheter was inserted into patient's body, when dr perform flushing on the catheter".There was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened picc kit including one, 3-lumen catheter for analysis.Signs of use in the form of biological material were observed on and within the catheter.Visual analysis of the catheter revealed three holes on the catheter body towards the juncture hub.The damage appears consistent with contact with a sharp instrument (i.E.Needle bevel, scalpel, etc.).The holes in the catheter body measured between 0-5 mm from the juncture hub.The length of the catheter body measured 56.10 cm, which is within the specification limits f 54.65-56.24 cm per catheter product drawing.The outer diameter of the catheter body measured 0.081", which is within the specification limits of 0.080"-0.085" per catheter extrusion product drawing.The catheter was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." a lab inventory syringe filled with water was used to flush each lumen.The proximal and medial lumens flushed as intended.Leaking was observed from the holes on the catheter body when the distal extension line was flushed.A device history record review was performed and no relevant findings were identified.The 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 complaint of a hole in the catheter body was confirmed through complaint investigation of the returned sample.Visual analysis revealed three holes on the catheter body towards the juncture hub.The damage appears consistent with contact with a sharp instrument (i.E.Needle bevel, scalpel, etc.).Despite the damage, the catheter met all relevant dimensional requirements.Based on the customer report and the sample received, unintentional use error (contact with sharps) likely caused or contributed to the reported event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: the proximal part of the catheter has a small hole that caused leaking.The leakage happened right after the catheter was inserted into patient's body, when dr perform flushing on the catheter".There was no reported patient harm or consequence.

• Brand Name: ARROW CG+ PICC SET: 3L 6FR X 55CM W/130CM 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: 20003311
• Report Number: 9680794-2024-00832
• Device Sequence Number: 17995831
• Product Code: LJS
• UDI-Device Identifier: 00801902095794
• UDI-Public: (01)00801902095794(11)230919(17)250308(10)33F23H0240(21)
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 01/26/2024

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: 03/08/2025
• Device Catalogue Number: PR-45563-HPHNL
• Device Lot Number: 33F23H0240
• 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: 01/26/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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