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

Model Number	IPN055200
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: "extension line (brown)/luer hub separation".The catheter was removed and a picc line was placed.No patient harm or consequence reported.
Event or Problem Description
The complaint is reported as: "extension line (brown) / luer hub separation".The catheter was removed and a picc line was placed.No patient harm or consequence reported.
Additional Manufacturer Narrative
(b)(4).The customer returned one 3-lumen cvc for evaluation.The catheter contained obvious signs of use in the form of biological material and the distal luer hub was returned with bandages.The distal luer was inadvertently separated during decontamination; however, this did not impact the outcome of the investigation.Visual examination revealed the distal luer hub was separated from the lumen.The luer contained remnants of extrusion within the hub.The outer diameter of the distal lumen measured to be 2.21 mm which is within specifications of 2.13 mm - 2.21 mm per product drawing.The inner diameter of the distal lumen measured to be 1.47 mm which is within specifications of 1.42 mm -1.50 mm per product drawing.This indicates the wall thickness measured within specifications.Functional inspection was performed to recreate the product's intended use.The ifu provided with this kit states "flush lumen(s) to completely clear blood from catheter." the proximal and medial extension lines were flushed using a lab inventory syringe to ensure there were no blockages.The distal end of the catheter was then clamped, and a water-filled lab inventory syringe pressurized each remai ning line.No leaks were detected in the proximal or medial extension lines.A manual tug test confirmed the proximal and medial extension lines were fully secured within the 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 kit informs 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 report of an extension line/luer hub separation was confirmed through the complaint investigation of the returned sample.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 extension line met all relevant dimensional requirements and a device history record review performed based on a potential lot number from sales history with no relevant findings.A capa has previously been initiated due to an increasing trend of cvc extension line leaks and separations.The root cause of this issue has not yet been determined.Teleflex will continue to monitor and trend complaints of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 20CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11619840
• Report Number: 3006425876-2021-00279
• Device Sequence Number: 3920088
• Product Code: DQY
• UDI-Device Identifier: 10801902146622
• UDI-Public: 10801902146622
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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: IPN055200
• Device Catalogue Number: CV-15703-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.