MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 3 LUMEN 12 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CA-25123-F
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The nurse from the user facility reported: catheter was inserted on (b)(6) and last used on (b)(6).The plan was to remove the catheter as the patient's renal failure had resolved.On (b)(6) in the evening, the patient's wife noted bleeding around the catheter.The nephrologist was contacted and once bw (anticoagulation ptt) were checked the catheter was removed.They noted the distal port of the catheter was missing and that is where the blood was coming from.There was a lot of clot around the catheter so the missing port was not noted until it was removed.There was no bleeding noted from the insertion site.The catheter was removed , and no patient harm was noted.The patient was discharged home the day after catheter removal.
Additional Manufacturer Narrative
(b)(4).The customer returned one 3-l cvc for evaluation.Signs of use were observed on the catheter body and inside the extension lines.Visual inspection of the catheter revealed the distal extension line separated along the body.The separated portion was not returned.The separation point is smooth.No stretching, necking, or deformation observed on the remaining extension line extrusion.The appearance of this damage is consistent with contact with a sharp object (scissors, scalpel, etc) during use.The separated extension line length measured 11mm which is not within the specifications of 68-74mm per product drawing.This indicates that at least 57mm of the extension line was separated and not returned.The distal extension line outer diameter measured 1.72mm, which is within the specifications of 1.68-1.78mm per product drawing.The distal extension line inner diameter measured 1.1938mm, which is within the specifications of 1.14-1.24mm per product drawing.This indicates that the wall thickness measured within specifications.Functional inspection of the catheter was performed per the instructions for use (ifu) provided with the kit which states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the medial and proximal extension lines were flushed using a lab inventory 10ml syringe.No leaks or blockages were observed.A manual tug test confirmed both the medial and proximal extension lines were secured to their respective luer hubs.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu provided with the 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 indic ated stabilization locations.".The customer report of an extension line separation was confirmed through complaint investigation of the returned sample.Visual ins pection revealed the distal extension line separated approximately 11mm from the juncture hub.The damage appeared consistent with contact with a sharp object during use.The extension line met all relevant dimensional and functional requirements, and a device history record review was performed based on a potential lot with no relevant findings.Based on the customer report and the appearance of the damage, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
The nurse from the user facility reported: catheter was inserted on 20 july and last used on 31 july.The plan was to remove the catheter as the patient's renal failure had resolved.On 06 august in the evening, the patient's wife noted bleeding around the catheter.The nephrologist was contacted and once bw (anticoagulation ptt) were checked the catheter was removed.They noted the distal port of the catheter was missing and that is where the blood was coming from.There was a lot of clot around the catheter so the missing port was not noted until it was removed.There was no bleeding noted from the insertion site.The catheter was removed , and no patient harm was noted.The patient was discharged home the day after catheter removal.

• Brand Name: ARROW CVC KIT: 3 LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 17756898
• Report Number: 9680794-2023-00652
• Device Sequence Number: 15119506
• Product Code: FOZ
• UDI-Device Identifier: 10801902157932
• UDI-Public: 10801902157932
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2023

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 Catalogue Number: CA-25123-F
• Device Lot Number: 33F23B0809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/13/2023
• 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