MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Cut In Material (2454)

Patient Problems Hematoma (1884); Swelling (2091); Numbness (2415)

Event Date 02/08/2018

Event Type  Injury  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd (b)(6) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation: a sample is not available for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.Without a sample, an absolute root cause for this incident cannot be determined.(b)(6).

Event Description

It was reported during use of the unspecified catheter an ¿arterial line cannula was removed by staff nurse as patient no longer required monitoring post op liver transplant.On checks as per protocol noted that not all of the cannula was removed, therefore part of the line left in patient's left radial artery.Details of injury (to patient, care or healthcare professional): approximately an hour after incident occurred left hand began to swell and further medical opinion source.Action taken (includes any action by patient, care or healthcare professional, or by the manufacturer or supplier) consultant informed immediately who reviewed patient.Ultrasound doppler performed approximately 3-hrs post incident and patency to blood vessels confirmed.Patient and family informed of incident.Radial pulses, capillary refill time and left arm elevated with pillows.Patient sent for left radial artery repair next day.Hematoma around site but no visible cannula tip seen in artery or surrounding tissues.Patient had worsening left hand numbness and swelling on following day - went back to theatres for left radial embolectomy and radial artery repair.Shaft of cannula and hub examined by medical engineering looks like has been cut, no evidence of damage to cannula or shearing.¿.

Manufacturer Narrative

Investigation summary: 1 used actual sample was returned for investigation.The manufacturing process was reviewed and there is no process in the manufacturing facilities that could have caused this nonconformance.The long piece of broken catheter is 3.9cm in length.The broken off portion of the catheters was examined under microscope and observed smooth edges at the edge of the broken off portion.Broken catheter was observed on the actual sample.Root cause: the broken off portion of the catheter was examined under microscope and observed smooth edges at the edge of the broken off portion.Hence, the broken catheter could have probably be cut by sharp object.The manufacturing process was reviewed and there is no process in the manufacturing facilities that could have caused this nonconformance.There is an automated vision inspection machine at the arterial cannula assembly machine to check and auto reject parts not meeting the lie distance requirement.A broken catheter will automatically be rejected as the lie distance will be out of specification.

• Brand Name: UNSPECIFIED INTRAVASCULAR CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7322632
• MDR Text Key: 101836404
• Report Number: 2243072-2018-00116
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/07/2018
• Supplement Dates Manufacturer Received: 02/26/2018
• Supplement Dates FDA Received: 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention