MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM; CATHETER PERCUTANEOUS

Model Number	IPN918463
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that " (b)(6) hospital, reports a product deviation on arrow cvc.The cvc snapped off close to the luer connection where the 3-way stop cock is mounted.Fortunately, clamps on the extension line were clamped off since the lumen was not in use.The catheter had been in the patient for 28 days.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).The report of an extension line/luer hub separation was confirmed through complaint investigation of the returned sample.Visual inspection of the catheter revealed the proximal luer hub was separated from its extension line; however, the proximal luer hub was not returned.The proximal extension line was knotted in two locations as seen in the customer provided photo.The separation points on the proximal extension line appeared uniform and slightly tapered.During dimensional analysis, the outer diameter of the proximal extension line was smaller than specifications.Thinning of the extrusion wall can occur when a tensile force is applied to the extension line causing the material to stretch/elongate.The catheter met all relevant functional requirements.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." without the luer hub returned to evaluate the nature of the break, the potential cause for the narrowing of the extension line could not be determined.A device history record review was performed, and no relevant findings were identified.Based on the information provided and the sample received, the root cause could not be determined.Teleflex will continue to monitor and trend complaints of this nature.
Event or Problem Description
It was reported that " (b)(6) hospital, (b)(6), reports a product deviation on arrow cvc.The cvc snapped off close to the luer connection where the 3-way stop cock is mounted.Fortunately, clamps on the extension line were clamped off since the lumen was not in use.The catheter had been in the patient for 28 days.Additional information has been requested.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18866111
• Report Number: 3006425876-2024-00217
• Device Sequence Number: 19667572
• Product Code: DQY
• UDI-Device Identifier: 00801902102171
• UDI-Public: 00801902102171
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/13/2024

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 Model Number: IPN918463
• Device Catalogue Number: CS-15854-E
• Device Lot Number: 71F21F1343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2021
• 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