MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Model Number	IPN030757
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the nurse was withdrawing blood from the central line and the brown luer hub separated from the catheter.No patient harm was reported.The patient had to have a picc line inserted.The patient's condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported the nurse was withdrawing blood from the central line and the brown luer hub separated from the catheter.No patient harm was reported.The patient had to have a picc line inserted.The patient's condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer provided one image of the luer hub for analysis.The image shows the separation of the luer hub.The customer also returned one distal luer hub for analysis.The remainder of the catheter was not returned for analysis.No definite signs of use were observed on the luer hub.Visual analysis revealed that the separation of the extension line occurred directly adjacent to the luer hub.The separation point appeared uneven and jagged.Remnants of the extension line were still molded and visible within the luer hub.Visual inspection of the remainder of the extension line could not be performed as it was not returned for evaluation.The inner diameter of the distal extension line within the luer hub measured 1.4224mm, which is within the specification limits of 1.42mm - 1.50mm per the proximal extension line extrusion graphic.Dimensional inspection of the remainder of the extension line could not be performed as it was not returned for evaluation.Functional inspection of the catheter could not be performed as the entire catheter was not returned for analysis.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 and several findings were identified.One of the findings is consistent with the failure mode reported by the customer and the returned separated luer hub.The customer report of an extension line/luer hub separation was confirmed through complaint investigation of the returned sample.Visual inspection revealed the distal luer hub separated from the extension line.Based on the customer report, returned sample, and manufacturing process review, manufacturing likely caused or contributed to this event.A capa has previously been initiated due to an increasing trend of cvc extension line leaks and separations.Corrective actions have not yet been implemented.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17843563
• Report Number: 3006425876-2023-00930
• Device Sequence Number: 4401901
• Product Code: DQY
• UDI-Device Identifier: 00801902028983
• UDI-Public: 00801902028983
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (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): 09/04/2023

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: IPN030757
• Device Catalogue Number: CS-12854-E
• Device Lot Number: UNKNOWN
• 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: 09/04/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 10/25/2023
• 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