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

Model Number IPN917654

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that "when the product was took out of packaging, it was noticed that the catheter tip is kinked." additional information was received that device may have been used on the patient.

Manufacturer Narrative

(b)(4).The customer returned a 3-l cvc and an opened kit for analysis.Signs of use in the form of biological material was observed on the catheter, which contradicts the customer report that the defect was observed prior to use.Upon performing functional testing, signs-of-use were also observed inside the catheter.Visual analysis revealed that the catheter body was bent near the distal end towards the tip.The bend in the catheter body occurred at 25 mm from the distal tip.The catheter body total length measured 320 mm, which is within the specification limits of 310-330 mm per the catheter graphic.The catheter body outer diameter measured 2.39 mm, which is within the specification limits of 2.39-2.49 mm per the catheter body extrusion graphic.Functional inspection was performed in an attempt to recreate the product's intended use.The ifu provided with this kit states: "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." all of the lumens were flushed using a 10ml lab inventory syringe to test for blockages.No blockages were observed in the proximal and distal lumen.However, biological material was observed exiting the medial lumen.Once the biological material was removed, the catheter flushed as expected.The distal end of the catheter was then occluded, and each lumen was pressurized to 300 kpa for 30 seconds to test for leaks.No leaks were observed.The returned guide wire was passed through the distal lumen of each catheter body.The guide wire was able to pass completely through each catheter.Slight resistance was observed at the kinked portions of each catheter.The manufacturing and packaging sites were consulted.The packaging site stated that this defect could not have occurred during their process.Per manufacturing, based on the evidence of biological material, it is probable that the root cause is undue force applied by the user.However, since there is a discrepancy between the returned sample and the customer reported time of discovery, the root cause could not be determined.A device history record review was performed with no relevant findings to suggest a manufacturing related cause.The ifu provided with this kit states: "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the customer complaint of a bend in the catheter was confirmed through complaint investigation of the returned sample.The returned catheter passed all relevant dimensional testing.A device history record review was performed with no evidence to suggest a manufacturing related cause.The customer reported the defect was found prior to use; however, the returned sample contained obvious signs of use.Therefore , the root cause of this issue could not be determined due to the discrepancy between the returned sample and the reported complaint by the customer.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that "when the product was took out of packaging, it was noticed that the catheter tip is kinked." additional information was received that device may have been used on the patient.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7FR X 30CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11832929
• MDR Text Key: 250985033
• Report Number: 3006425876-2021-00478
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/19/2022
• Device Model Number: IPN917654
• Device Catalogue Number: DE-24703-LHA
• Device Lot Number: 71F20K1520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1