MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 3-LUMEN 7FR X 20CM; CATHETER INTRAVASCULAR THERAPE

Model Number IPN030687

Device Problem Fluid/Blood Leak (1250)

Patient Problems Erythema (1840); Pain (1994)

Event Date 08/28/2023

Event Type  malfunction  

Event Description

It was reported that "the cvc could be flushed and aspirated without any problems.Approx.10 min after the start of therapy, the patient's t-shirt was wet at the level of the cvc.User paused all infusions and checked the puncture site.Infusion solution (daunoblastin) in the dressing and on the patient's skin in the thoracic area.All lumens of the cvc were aspirated and then flushed.Cvc removed and wound care performed.After removal of the cvc, a small hole was discovered on the blue part of the cvc." a new cvc was placed.It was reported there was "psychological stress factor for the patient" and "painful areas on the skin with redness with unclear consequences".Additional information was requested but was not available at the time of this report.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that "the cvc could be flushed and aspirated without any problems.Approx.10 min after the start of therapy, the patient's t-shirt was wet at the level of the cvc.User paused all infusions and checked the puncture site.Infusion solution (daunoblastin) in the dressing and on the patient's skin in the thoracic area.All lumens of the cvc were aspirated and then flushed.Cvc removed and wound care performed.After removal of the cvc, a small hole was discovered on the blue part of the cvc." a new cvc was placed.It was reported there was "psychological stress factor for the patient" and "painful areas on the skin with redness with unclear consequences".Additional information was requested but was not available at the time of this report.

Event Description

It was reported that "the cvc could be flushed and aspirated without any problems.Approx.10 min after the start of therapy, the patient's t-shirt was wet at the level of the cvc.User paused all infusions and checked the puncture site.Infusion solution (daunoblastin) in the dressing and on the patient's skin in the thoracic area.All lumens of the cvc were aspirated and then flushed.Cvc removed and wound care performed.After removal of the cvc, a small hole was discovered on the blue part of the cvc." a new cvc was placed.It was reported there was "psychological stress factor for the patient" and "painful areas on the skin with redness with unclear consequences".

Manufacturer Narrative

Qn#(b)(4).Additional information received from the customer indicates the condition of the patient was "stable".It was also reported that the patient experienced shortness of breath, psychological stress, and pain; and the customer confirmed that no air, particulate, or component entered the vasculature.The customer returned one 3-l catheter for evaluation.Definite signs of use were observed along the catheter extrusion.The extension lines were severed and not returned for analysis.The suture thread was also present on the juncture hub and wrapped around the catheter extrusion.The suture was removed to further analyze the catheter juncture hub and extrusion.After failing functional testing, visual analysis revealed a small hole in the catheter extrusion.Microscopic examination revealed that the edges of the hole were smooth and uniform.The appearance of the hole is consistent with damage resulting from contact with a sharp instrument (i.E.Needle bevel, scalpel, scissors, etc.).It was also noted that the extrusion had a dried and flaky residue towards the tip and adjacent to the location of the leak which appears consistent with dressing/adhesive residue.The overall length of the catheter extrusion measured 217mm which is within the specification limits of 207mm - 227mm per the catheter product drawing.The outer diameter of the catheter extrusion measured 2.418mm which is within the specification limits of 2.39mm - 2.49mm per the extrusion product drawing.The catheter was functionally tested per the instructions for use (ifu) provided with this kit which instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s).".With the tip of the catheter extrusion was occluded, the proximal extension line was pressurized using a lab inventory syringe/18ga introducer needle assembly, and a leak was identified adjacent to the 15cm marking on the catheter extrusion.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.No relevant findings were identified.The instructions-for-use provided with this kit informs the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations.".The customer report of a leaking catheter was confirmed through investigation of the returned sample.Visual and functional analysis revealed a small hole on the extrusion body adjacent to the 15cm marking.The appearance of the hole is consistent with damage resulting from contact with a sharp instrument (i.E.Needle bevel, scalpel, scissors, etc).Despite this, the catheter passed all relevant dimensional requirements, and a device history record review performed based on a potential lot revealed no relevant findings to suggest a manufacturing related issue.Therefore, based on the customer report that the damage was observed during use and the appearance of the damage, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7FR X 20CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• 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: 17797818
• MDR Text Key: 324018279
• Report Number: 3006425876-2023-00912
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN030687
• Device Catalogue Number: CH-45703-USZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 10/17/2023; 11/20/2023
• Supplement Dates FDA Received: 10/18/2023; 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DAUNOBLASTIN.; DAUNOBLASTIN.; DAUNOBLASTIN.
• Patient Sex: Female