MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI MULTI-LUMEN CVC KIT: 3-L 7FR X 8"; CATHETER,INTRAVASCULAR,THERAP

Model Number	IPN037417
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint is reported as "the female luer lock hub on the end of the lumen came off.The lumen had to be clamped and the catheter was replaced." no patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of extension line and luer hub separation was able to be confirmed by the photo.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "warning: open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure." the customer report of extension line and luer hub separation was confirmed by visual inspection of the customer supplied photo.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
The complaint is reported as "the female luer lock hub on the end of the lumen came off.The lumen had to be clamped and the catheter was replaced.".No patient harm reported.The patient's condition is reported as fine.
Event or Problem Description
The complaint is reported as "the female luer lock hub on the end of the lumen came off.The lumen had to be clamped and the catheter was replaced.".No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The complaint of extension line and luer hub separation was able to be confirmed by the photo.The customer also returned one 3-l cvc for investigation.Signs of use were observed on the catheter and extension lines.The medial extension line appeared intentionally cut.Visual inspection revealed the distal extension line was separated directly adjacent to the luer hub.Remains of the extension line were visible inside the separated distal luer hub.The separation point on the extension lines were rough and jagged.The total length of the catheter body measured to be 215mm, which is within the specifications of 207-227mm per product drawing.The outer diameter of the distal lumen measured to be 0.08445" which is within specifications of 0.084"-0.088" per product drawing.The inner diameter of the distal lumen inside the luer hub measured to be 0.058", which is within the specifications of 0.055"-0.059" per product drawing.This indicates that the wall thickness measured within specifications.The catheter was functionally tested per the instructions for use (ifu).The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the proximal lumen was flushed using a water-filled lab inventory syringe.The lumen flushed as expected.A manual tug test confirmed the proximal extension line was fully secured within the luer hub.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." the customer report of an extension line/luer hub separation was confirmed through complaint investigation.Visual analysis revealed that the distal extension line had separated adjacent to the luer hub.It was noted that remains of the extension line were found within the luer hub.The returned sample passed all relevant dimensional inspections.The type of damage observed is consistent with a manufacturing issue in the cvc lines.A non-conformance has been initiated to further investigate this issue.

• Brand Name: ARROW PI MULTI-LUMEN CVC KIT: 3-L 7FR X 8"
• 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: 15442702
• Report Number: 9680794-2022-00571
• Device Sequence Number: 5672918
• Product Code: FOZ
• UDI-Device Identifier: 10801902125207
• UDI-Public: 10801902125207
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2022

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: 10/31/2023
• Device Model Number: IPN037417
• Device Catalogue Number: ASK-45703-PSSM1
• Device Lot Number: 13F22D0293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 10/11/2022; 01/22/2023
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 10/12/2022; 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2022
• 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; NOT REPORTED
• Patient Sex: Unknown