MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER PERCUTANEOUS

Catalog Number CV-14703

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that there was a leakage on the distal line of the catheter where the junction hub and the brown luer hub is.Air bubbles were observed.Clinical consequences: there was no consequence for the patient.The distal line was clamped , and the catheter was removed.

Manufacturer Narrative

Qn#(b)(4).The customer returned one, three-lumen cvc for evaluation.Signs-of-use in the form of biological material was observed inside the distal extension line.Additionally, the catheter body was intentionally cut approximately 4cm from the juncture hub.The severed portion was not returned by the customer.Visual analysis of the returned sample revealed that the distal extension line contained a small hole directly adjacent to the brown luer hub.This hole is consistent with undue force being applied on the extension line.After failing dimensional inspection, microscopic analysis revealed that the distal extension line was tapered/stretched near the juncture hub.The damage observed would affect extension line dimensions and likely caused the extrusion to not meet the length and outer diameter dimensional requirements.The stretching of the extension line is also consistent with undue force being applied on the extension line.The distal extension line from the luer hub to the juncture hub measured 100mm, which is longer than the nominal value of 85mm per the catheter graphic.The extension line outer diameter measured 2.10mm , which is not within the specification limits of 2.13mm-2.21mm per the distal extension line extrusion graphic.The extension line inner diameter measured 1.4224mm, which is within the specification limits of 1.42mm-1.50mm per the distal extension line extrusion graphic.Important side note: the proximal extension line length measured 134mm, which is close to the nominal value of 130mm per the catheter graphic.The medial extension line length measured 110mm, which equals the nominal value of 110mm per the catheter graphic.This indicates that the returned sample matches what was reported by the customer.The catheter was flushed using a lab inventory syringe to ensure there were no blockages.The distal end was then clamped, and a water-filled lab inventory syringe pressurized each line.The distal lumen leaked near the luer hub when pressurized.No leaks were detected in the proximal or medial extension lines.A manual tug test was performed to determine if the extension lines were secure within their respective hubs (despite any pre-existing damage).While testing the distal extension line, the extrusion completely separated at the hole.The proximal and medial extension lines were secure within their hubs.Manufacturing engineering was contacted to determine a potential root cause for the defect observed.It was indicated that the damage is consistent with excessive force being applied to the medial luer hub of the extension line.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit cautions the user, "do not apply excessive force in removing guide wire or catheters.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained, and further consultation requested".The customer report of an extension line leak during use was confirmed by complaint investigation of the returned sample.The distal extension line contained a small hole adjacent to the luer hub.Based on feedback from manufacturing engineering, this damage is consistent with undue force being applied to the distal extension line luer hub.The distal extension line did not meet dimensional requirements; however, it is assumed that this was a result of the damage (stretching/tapering) observed on the extrusion.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that there was a leakage on the distal line of the catheter where the junction hub and the brown luer hub is.Air bubbles were observed.Clinical consequences: there was no consequence for the patient.The distal line was clamped , and the catheter was removed.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9172974
• MDR Text Key: 161804190
• Report Number: 3006425876-2019-00761
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• 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: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: CV-14703
• Device Lot Number: 71F19E1154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Date Manufacturer Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.