MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-25854-E

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint is reported as, "leakage was detected during medication injection through the distal lumen.Md tried to find the point where the leak occurred.So the md removed it from the patient and perfused the saline into the distal lumen of the cvc.A leak was found in the extension line just below the distal lumen hub." it was reported the patient was in the "ward" and cvc reinsertion was required.

Manufacturer Narrative

Qn#(b)(4).The customer returned one 4-lumen cvc for evaluation.Signs-of-use in the form of biological material was observed inside the extension lines.Visual analysis revealed that the distal extension line contained a hole directly adjacent to the luer hub.Microscopic examination confirmed the hole.No other defects or anomalies were observed.The distal extension line outer diameter measured 2.14mm, which is within the specification limits of 2.13mm-2.21mm per the distal extension line extrusion graphic.The distal extension line inner diameter measured 1.448mm, which is within the specification limits of 1.42mm-1.50mm per the distal extension line extrusion graphic.All four lumens were initially flushed using a water-filled lab inventory syringe to ensure no blockages were present.The distal end of the catheter was then clamped, and each lumen was pressurized using a water-filled lab inventory syringe.When the distal line was pressurized, a small leak was detected near the luer hub of the extension line.No leaks were detected in the other lines.A manual tug test confirmed all four luers were fully secured to their respective extension lines.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 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 customer report of an extension line leak was confirmed by functional and visual inspection of the returned sample.The distal extension line contained a small hole adjacent to the luer.A device history record review was performed based on 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 reports of this nature.

Event Description

The complaint is reported as: "leakage was detected during medication injection through the distal lumen.Md tried to find the point where the leak occurred.So the md removed it from the patient and perfused the saline into the distal lumen of the cvc.A leak was found in the extension line just below the distal lumen hub".It was reported the patient was in the "ward" and cvc reinsertion was required.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10742146
• MDR Text Key: 213464908
• Report Number: 3006425876-2020-00903
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K962577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-25854-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.