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

Model Number IPN030593

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problems Edema (1820); No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product (bo-25854) not intended for sale in the us.Similar product/component sold in the us.

Event Description

Customer reported that after a week of chemotherapy, the extension line leaked.A hole was noted in the device.The device was removed.

Manufacturer Narrative

(b)(4).The customer returned one 4-lumen cvc for evaluation.The catheter was returned with non-arrow injection caps connected to each luer.The catheter was also returned with a box clamp secured to the catheter body.Visual examination did not reveal any defects or anomalies.The total length of the catheter body measured to be 220 mm which is within specifications of 207-227 mm per product drawing.The catheter was initially flushed 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.No leaks were detected.The returned catheter was then connected to the lab inventory leak tester.Per amrq-000071 rev.11, which is based on bs en iso 10555-1 annex c, no catheter liquid leakage shall occur in the form of a falling drop of water when pressurized to 300 kpa for 30 seconds.The leak tester was pressurized to 300 kpa and the timer was started for 30 seconds.No leaks were detected from any region of the catheter.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 instructions-for-use provided with this kit cautions the user, "use of a syringe smaller than 10 ml to irrigate or declot an occluded catheter may cause intraluminal leakage or catheter rupture." the customer report of a catheter body leak could not be confirmed by complaint investigation of the returned sample.The catheter passed all relevant visual, dimensional, and functional testing, and a device history record review was performed based on sales history with no relevant findings.No problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

Customer reported that after a week of chemotherapy, the extension line leaked.A hole was noted in the device.The device was removed.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 20CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10488291
• MDR Text Key: 205498962
• Report Number: 3006425876-2020-00802
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

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 Operator: Health Professional
• Device Model Number: IPN030593
• Device Catalogue Number: BO-25854
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 09/09/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1