MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 3L 6FRX55CM W/80CM HYDRO NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-35563-HPHNM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "pink lumen of picc line snaped from patient force.The pink lumen had no clap when it snapped, she took one of the clamps from another lumen to clamp it, end of lumen also covered with tegaderm.7f educator discussed with va nurse practitioner katie, requested picc to be removed.Picc line is removed under aseptic technique and protocol, patient vital signs are between the flags, no signs of infection at the insertion site." a piv was inserted to continue the treatments.There was no patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
(b)(4).The customer provided one image for analysis.The image confirmed the reported issue of the distal extension line luer hub becoming detached.It shows the catheter in use, with the distal extension line occluded by a slide clamp and covered by a bandage or adhesive.The customer also returned a 3-lumen picc catheter for analysis.Signs of use in the form of biological material were observed.The catheter body appeared to have been intentionally severed from the distal end; however, the severed portion was not returned.Additionally, the detached distal luer hub and slide clamp were not included in the return.Visual inspection of the remaining extension line showed signs of stretching and narrowing at the site of separation, indicative of mechanical stress.Microscopic examination confirmed the separation and revealed rough, jagged edges at the break.However, without the severed portion of the extension line, the nature of the break and cause of the separation cannot be definitively determined.The remaining distal extension line measured 64mm in length from the juncture hub to the point of separation from the luer hub.The distal line outer diameter measured 0.0934", which is within the specification limits of 0.093" - 0.097" per the distal extension line extrusion product drawing.The distal extension line inner diameter measured 0.058", which is within the specification limits of 0.055" - 0.059" per the distal extension line product drawing.The catheter body measured 16 1/8", which is not within the specification limits of 21.921" - 22.171" per the catheter product drawing.This suggests that the catheter was likely trimmed between 5.796" - 6.046".Functional analysis could not be performed due to the severity of the damage.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs 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 separated extension line was confirmed during the investigation.Visual analysis indicated that the extension line was separated adjacent to the luer hub of the distal extension line; however, the separated portion was not returned for evaluation.The extension line met all relevant dimensional specifications, and a device history record review did not reveal any relevant findings.The nature of the separation cannot be confirmed without the separated portion of the extension line also being returned.Therefore, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "pink lumen of picc line snaped from patient force.The pink lumen had no clap when it snapped, she took one of the clamps from another lumen to clamp it, end of lumen also covered with tegaderm.7f educator discussed with va nurse practitioner katie, requested picc to be removed.Picc line is removed under aseptic technique and protocol, patient vital signs are between the flags, no signs of infection at the insertion site." a piv was inserted to continue the treatments.There was no patient harm or injury.The patient's current condition is reported as "fine".

• Brand Name: ARROW PI PICC 3L 6FRX55CM 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: 22675579
• Report Number: 9680794-2025-00647
• Device Sequence Number: 21043848
• Product Code: LJS
• UDI-Device Identifier: 00801902095657
• UDI-Public: (01)00801902095657(11)240623(17)260228(10)33F24E0760(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K080604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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-35563-HPHNM
• Device Lot Number: 33F24E0760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2024
• 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.
• Patient Sex: Unknown