MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Catalog Number CV-12854

Device Problems Obstruction of Flow (2423); Material Twisted/Bent (2981)

Patient Problems Low Blood Pressure/ Hypotension (1914); Insufficient Information (4580)

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "an extension line twisted, and it's blocking the good flow of the medication when using the syringe there is suppression and doesn't deliver the medication as it should.The patient does not receive the medication as he should, causing an increase in blood pressure on the patient.The extension line is bent to try to remove the twisted part." additional information reports "during the incident the patient's blood pressure dropped because the device was no longer delivering the drug properly.The problem was solved by turning the line upside down to remove the twisted part." the patient's current status is unknown at this time.

Manufacturer Narrative

(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 taken 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 "an extension line twisted, and it's blocking the good flow of the medication when using the syringe there is suppression and doesn't deliver the medication as it should.The patient does not receive the medication as he should, causing an increase in blood pressure on the patient.The extension line is bent to try to remove the twisted part." additional information reports "during the incident the patient's blood pressure dropped because the device was no longer delivering the drug properly.The problem was solved by turning the line upside down to remove the twisted part." the patient's current status is unknown at this time.

Manufacturer Narrative

(b)(4).The customer returned one, 4-lumen catheter for analysis.Signs of use were observed.Visual analysis revealed the catheter body was severed.Additional information from the customer does not report a severing of the catheter body which suggests the catheter was intentionally cut after the defect was observed.No signs of a blockage were observed within the lumens at the distal end.No signs of kinking were observed on either of the four extension lines.The catheter body was severed 82 mm from the juncture hub.The outer diameter of the 12.7 cm medial extension line measured 2.21 mm, which is within the specification limits of 2.13-2.21 mm per the medial extension line extrusion drawing.The inner diameter of the 12.7 cm medial extension line measured 1.40 mm, which is within the specification limits of 1.40-1.48 mm per the medial extension line extrusion drawing.The outer diameter of the 14 cm medial extension line measured 2.21 mm, which is within the specification limits of 2.13-2.21 mm per the medial extension line extrusion drawing.The inner diameter of the 14 cm medial extension line measured 1.42 mm, which is within the specification limits of 1.42-1.50 mm per the medial extension line extrusion drawing.The outer diameter of the distal extension line measured 2.21 mm, which is within the specification limits of 2.13-2.21 mm per the distal extension line extrusion drawing.The inner diameter of the distal extension line measured 1.42 mm, which is within the specification limits of 1.42-1.50 mm per the distal extension line extrusion drawing.The outer diameter of the proximal extension line measured 2.15 mm, which is within the specification limits of 2.13-2.21 mm per the proximal extension line extrusion drawing.The inner diameter of the proximal extension line measured 1.42 mm, which is within the specification limits of 1.42-1.50 mm per the proximal extension line extrusion drawing.The catheter was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." a lab inventory filled with water was used to flush each extension line.No signs of a blockage were observed when each lumen was flushed.A manual tug test confirmed that the extension lines were secure within their respective luer hubs.Additional information from the customer was reviewed as a part of this complaint investigation.The customer stated , "the problem was solved by turning the line upside down to remove the twisted part." this suggests the extension line became twisted/kinked during use and was able to return to patency when the customer repositioned the extension line.However, it is unknown which extension line became twisted, and whether unintentional catheter manipulation or patient movement may have contributed to the obstruction in the extension line.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 ifu provided with this kit informs the user , "minimize catheter manipulation throughout procedure to maintain proper catheter tip position.Do not alter the catheter, guidewire or any other kit/set component during insertion, use or removal." the customer report of an extension line kink was not confirmed through investigation of the returned sample.Visual and functional inspections of the catheter did not reveal any defects or anomalies with either of the four extension lines.The catheter met all relevant dimensional and functional requirements.Based on the customer report and the returned sample, the root cause cannot be determined as it is unknown which extension line became twisted, and whether unintentional catheter manipulation or patient movement may have contributed to the obstruction in the extension line.Teleflex will continue to monitor and trend on reports of this nature.

Event Description

It was reported "an extension line twisted, and it's blocking the good flow of the medication when using the syringe there is suppression and doesn't deliver the medication as it should.The patient does not receive the medication as he should, causing an increase in blood pressure on the patient.The extension line is bent to try to remove the twisted part." additional information reports "during the incident the patient's blood pressure dropped because the device was no longer delivering the drug properly.The problem was solved by turning the line upside down to remove the twisted part." the patient's current status is unknown at this time.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 19058954
• MDR Text Key: 339793082
• Report Number: 3006425876-2024-00338
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10801902029239
• UDI-Public: 10801902029239
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

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: CV-12854
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Congenital Anomaly
• Patient Sex: Male