MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI-LUMEN/PSI KIT; INTRODUCER CATHETER

Catalog Number	AK-11142-D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the proximal lumen on the introducer broke off when the rn was removing the dressing for a dressing change".Patient's current condition is "unknown".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer report of a separated extension line was confirmed through complaint investigation of the returned sample.The customer returned one mac sheath for evaluation.Signs-of-use were observed on the sheath and inside the extension lines.Visual inspection revealed the proximal extension line separated near the juncture hub.The edges of separation appeared angled and smooth.The appearance of the damage is consistent with unintentional contact with a sharp object (e.G.Scalpel) during use.The proximal extension line separated 3mm via calibrated ruler from the juncture hub.The sheath total length measured 99mm via calibrated ruler which was within the specifications of 98-102mm per product drawing.Functional inspection of the proximal extension line could not be performed due to the damage.Functional inspection of the distal line was performed per the instructions-for-use (ifu) provided with the kit which warns the user, "flush and connect distal side port to appropriate line as necessary.Confirm and monitor proximal port by aspirating until free flow of venous blood is observed." the distal extension line flushed as expected.A manual tug test confirmed the distal extension line was secured to its luer hub.The instructions-for-use (ifu) provided with the kit warns the user, "do not secure, staple and/or suture directly to outside diameter of device body or extension lines to reduce risk of cutting or damaging the device or impeding device flow.Secure only at indicated stabilization locations." a device history record review was performed based on a potential lot number from sales history with no relevant findings.The sheath met all relevant dimensional and functional requirements.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "the proximal lumen on the introducer broke off when the rn was removing the dressing for a dressing change".Patient's current condition is "unknown".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

• Brand Name: ARROW MULTI-LUMEN/PSI KIT
• Common Device Name: INTRODUCER CATHETER
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18558158
• Report Number: 9680794-2024-00046
• Device Sequence Number: 7597222
• Product Code: FOZ
• UDI-Device Identifier: 20801902121916
• UDI-Public: 20801902121916
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K002507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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 Catalogue Number: AK-11142-D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/27/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 01/30/2024
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown