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

Catalog Number CS-45854-HP

Device Problem Stretched (1601)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2023

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: t bolus (80mls, gray lumen); other lumens used to deliver intermittent iv analgesia, prbcs, and fluids and antibiotic, sqn# (b)(4).

Event Description

It was reported the patient had a ct scan on (b)(6) 2023, and on (b)(6) 2023, the clear extension line looked "flattened".The line was clamped and immediately removed.No leaking noticed around line or insertion site.It was reported the other lumens were used to deliver therapy until the cvc was removed.A new cvc was placed.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

Continuation of d11: t bolus (80mls, gray lumen); other lumens used to deliver intermittent iv analgesia, prbcs, and fluids and antibioticsqn#1900099615 the customer provided one photo for analysis.The photo shows a 4-l cvc whose gray medial extension line (pressure injectable) was stretched and ballooned down most of the extension line body.The customer also returned one 4-l cvc for evaluation.Signs of use were observed on the catheter body and inside the extension lines.Visual inspection revealed the gray medial extension line stretched and ballooned.This damage is consistent with unintentional over-pressurization of the extension line during use.The stretched portion of the medial extension line was located 1-67mm from the luer hub.The catheter length measured 218mm , which is within the specifications of 207-227mm per product drawing.The distal extension line outer diameter in an area not stretched/ballooned measured 0.0860", which is within the specifications of 0.084-0.088" per product drawing.The extension line inner diameter could not be accurately measured due to the damage.Functional inspection was performed per the product instructions for use which states "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the gray medial extension line was flushed using a lab inventory 10ml syringe.Water exited out the catheter as expected.No leaks or blockages were observed.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 (ifu) provided with this kit warns the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300 psi) to reduce risk of intraluminal leakage or catheter rupture.Warning: open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure.Precaution: do not exceed ten (10) injections or catheter's maximum recommended flow rate located on product labeling and catheter luer hub to minimize the risk of catheter failure and/or tip displacement.Pressure limit settings on injector equipment may not prevent over pressurizing an occluded or partially occluded catheter." the customer report of a stretched/ballooned extension line was confirmed through complaint investigation of the returned sample.Visual inspection revealed the gray medial extension line was partially ballooned.This damage is consistent with over pressurization of the extension line during use.The catheter met all relevant dimensional and functional requirements, and a device history record review based on sales history was performed with no relevant findings.Based on these circumstances, unintentional use error (overpressure) likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported the patient had a ct scan on 27 january 2023, and on 28 january 2023, the clear extension line looked "flattened".The line was clamped and immediately removed.No leaking noticed around line or insertion site.It was reported the other lumens were used to deliver therapy until the cvc was removed.A new cvc was placed.No patient harm was reported.The patient's condition is reported as fine.

• Brand Name: ARROW CVC KIT: 4-LUMEN 8.5FR X 20CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: 16452572
• MDR Text Key: 310364685
• Report Number: 3006425876-2023-00189
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

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
• Device Catalogue Number: CS-45854-HP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 03/21/2023
• Supplement Dates FDA Received: 03/22/2023
• 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: DRUG AND FLUSH (10ML/HOUR, UNKNOWN LUMEN), CONTRAS; DRUG AND FLUSH (10ML/HOUR, UNKNOWN LUMEN), CONTRAS