MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Model Number	IPN030771
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: the white leur hub separated from the device when changing the dressing.The proximal channel was clamped, and the catheter was changed.There was no negative clinical consequence for the patient.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The customer report of an extension line/luer hub separation was confirmed through complaint investigation of the returned sample.The customer returned one 3-lumen catheter for analysis.The proximal luer hub was separated and not returned.Visual analysis revealed that the proximal luer hub separated from its extension line.The point of separation could not be determined without the proximal luer hub returned for analysis.The proximal extension line separation point appeared partly smooth and partly rough and jagged.The inner diameter (id) of the extension line at the separation point measured 0.058", or 1.4732mm via calibrated pin gauge, which is within the specification limits of 1.42mm - 1.50mm per the proximal extension line graphic.Functional inspection could not be performed as the rest of the catheter was not returned for analysis.The ifu provided with this 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." a device history record review was performed based on a potential lot from sales history, and no relevant findings were identified.Without the separated luer hub returned for analysis, the probable root cause cannot be determined from the available information.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that: the white leur hub separated from the device when changing the dressing.The proximal channel was clamped, and the catheter was changed.There was no negative clinical consequence for the patient.

• Brand Name: CVC SET: 3-LUMEN 7 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: 17180490
• Report Number: 3006425876-2023-00574
• Device Sequence Number: 20490537
• Product Code: DQY
• UDI-Device Identifier: 30801902125959
• UDI-Public: 30801902125959
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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 Model Number: IPN030771
• Device Catalogue Number: CS-15703
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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