MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number CV-17702-BZ

Device Problem Break (1069)

Patient Problems Death (1802); No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).It is reported that the patient died, but the non-compliance did not cause the patient's death per additional information received.

Event Description

The customer reports that when the doctor attempted to puncture (skin perforation) the needle broke.A new kit was used.No intervention reported.

Event Description

The customer reports that when the doctor attempted to puncture (skin perforation) the needle broke.A new kit was used.No intervention reported.

Manufacturer Narrative

Qn# (b)(4).The customer returned one introducer needle and lidstock for evaluation.Visual examination revealed the needle cannula was broken and separated just below the hub.A cross-section of the broken ends of the cannula revealed they are oval/d shaped indicating that the cannula was bent during insertion, which likely lead to the separation.Microscopic examination confirmed the dented cannula at the break.The separated cannula measured 63 mm in length from the broken end to the needle bevel tip.Approximately 1 mm of the needle cannula is visible protruding from the needle hub.The outer diameter of the cannula measured 0.0499" which is within specifications of 0.0495-0.0505" per needle cannula product specification.The inner diameter (measured from the undamaged distal tip) of the needle cannula measured to be 0.041" which is within specifications of 0.041-0.043" per product drawing.This indicates that the cannula wall thickness measured within specifications.The needle hub was attached to a lab inventory arrow raulerson syringe and the fit was secure.A device history record review was performed on the needle with no relevant findings.The ifu provided with this kit instructs the user, "insert introducer catheter/needle with attached syringe into vein alongside of locater needle and aspirate.Remove locater needle.Withdraw needle from introducer catheter.If no free flow of venous blood is observed after needle is removed, attach syringe to catheter and aspirate until good venous blood flow is established." the customer report of a broken introducer needle was confirmed through visual examination of the returned sample.The cannula was bent and broken just below the hub.The cannula met specifications for length and wall thickness and a device history record review did not reveal any manufacturing related issues.Based on the time of discovery and the sample evaluation, unintentional use error caused or contributed to this complaint.Teleflex will continue to monitor and trend for reports of this issue.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9746775
• MDR Text Key: 180632825
• Report Number: 9680794-2020-00085
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: CV-17702-BZ
• Device Lot Number: 14F18G0440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Date Manufacturer Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 86 YR