MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	ASK-45552-RH
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "pink hub detached when rolling/repositioning patient.Patient self discontinued picc the day before.Hard to confirm if damage due to patient or staff or both." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported that "pink hub detached when rolling/repositioning patient.Patient self discontinued picc the day before - hard to confirm if damage due to patient or staff or both." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one 2-lumen catheter for analysis.Signs of use were observed on the catheter body and within the extension lines.The catheter body was severed at the 51 cm marking, presumed to be intentional trimming prior to insertion.Microscopic analysis of the distal extension line showed that the luer hub was completely separated.The condition of the extension line extrusion appeared to be consistent with normal hub seating.Considering the customer's description that the "pink hub detached during patient repositioning" and that the "patient had self-discontinued the picc the day prior," the damage may have resulted from excessive tensile stress applied to the extension line during handling or repositioning, which could have contributed to the luer hub separation.Visual examination of the separated luer hub could not be performed, as the hub was not returned for evaluation.The outer diameter of the distal extension line measured 0.077" , which is out of the specification limits of 0.093-0.097" per distal extension line extrusion product drawing.Accurate measurement of the distal extension line's inner diameters could not be obtained because of the separated distal extension surface was uneven and irregular.A manual tug test confirmed that the proximal extension line was secure to its luer hub.Manufacturing was contacted and indicated that excessive pulling or tensile force on the extension line can cause extrusion elongation or hub detachment.Based on the available information, the catheter likely experienced significant mechanical stress during patient repositioning, which may have contributed to the separation.However, this cannot be confirmed without the separated hub returned for evaluation.A device history record review was performed and a relevant finding was identified.A non-conformance was initiated for lots 13c24h0717 and 13c24g1086 regarding extension line leakage during use.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 that the distal extension line was separated from the luer hub, and the extension line surface appeared rough and jagged at the point of separation.The manufacturing team indicated that excessive tensile or bending force applied during use can lead to extrusion elongation or hub detachment.The customer's report, stating that "the pink hub detached when rolling/repositioning the patient," suggests that undue tensile force during patient repositioning could have contributed to the detachment.Based on this information, mechanical stress during patient movement is considered a likely contributing factor.Since the luer hub was not returned, a complete evaluation of the bond interface could not be performed.Therefore, the root cause could not be determined.Teleflex will continue to monitor and trend similar complaints to identify any potential patterns or recurrence.

• Brand Name: ARROW PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS
• 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: 23452309
• Report Number: 9680794-2025-00895
• Device Sequence Number: 21084754
• Product Code: LJS
• UDI-Device Identifier: 10801902159967
• UDI-Public: (01)10801902159967(11)250313(17)260619(10)33F24L0348(21)
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

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
• Device Expiration Date: 06/19/2026
• Device Catalogue Number: ASK-45552-RH
• Device Lot Number: 33F24L0348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• 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