MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ARTERIAL CANNULA

Catalog Number 682245

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 12/15/2021

Event Type  Injury  

Event Description

It was reported that the bd arterial cannula experienced the catheter separating from the hub.The product defect resulted in medical intervention, with an ultrasound scan being administered where it was confirmed that the separated cannula remained embedded within the patient's left wrist.After consultation with their vascular team, it was determined that it was safe to leave the cannula for the time being, with follow-up planned for the following week.There has been no additional information provided regarding the final outcome of the incident.The following information was provided by the initial reporter: patient was recovering following an emergency laparotomy.I noticed that the arterial trace was giving obscure readings and the anaesthetist advised me to use non-invasive blood pressure (nibp) readings.He asked me to remove the arterial cannula prior to the patient going back to alex ward.As i began to withdraw the art cannula, i noticed a small blood clot sitting on the base of the cannula hub.As i withdrew the cannula further i saw that the cannula catheter was not attached to the hub.I asked 2 x colleagues for help, and pressure was applied to the wound site (left wrist).The emergency anaesthetist was then called for, and he asked for a sonosite scan so that he could confirm that the cannula catheter had been left in the patient's artery.The sonosite proved this was true.He then rang uhcw vascular team to ask for advice.He was advised via the vascular sho that as long as the patient had a palpable pulse in her left wrist, the hand was pink and warm, there was no discoloration, the patient felt no pain, or pins and needles and that due to the patient just having had emergency surgery, it would be safe to leave the broken cannula in site and that the vascular team would follow up during the next week.The patient was aware that there had been issue, but no official duty of candour was carried at this time, due to the effects of the anaesthetic.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: one photo was received by our quality team for evaluation.From the photo, a broken catheter was observed.A device history record could not be evaluated as the lot number is unknown.Based on the photos received, a root cause cannot be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.No dhr review can be performed as there is no batch number provided.No sample was received for this complaint.If a sample is received for this complaint, the broken catheter area can be observed and investigated to determine its cause.The complaint will be re-opened when there is a sample & batch number received for this complaint, the complaint trend will be monitored and tracked.

• Brand Name: BD ARTERIAL CANNULA
• Type of Device: ARTERIAL CANNULA
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13214892
• MDR Text Key: 286011505
• Report Number: 8041187-2021-01109
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2021

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: Health Professional
• Device Catalogue Number: 682245
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 01/10/2022
• 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): Required Intervention