MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON PRO SAFETY 18GA 1.3MM OD 45MM L; INTRAVASCULAR CATHETER

Catalog Number 393227

Device Problem Free or Unrestricted Flow (2945)

Patient Problem Air Embolism (1697)

Event Date 07/10/2023

Event Type  Injury  

Manufacturer Narrative

As no physical sample, lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a root cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.B3.The date received by manufacturer has been used for this field.

Event Description

It was reported that bd venflon pro safety 18ga 1.3mm od 45mm l had air bubbles / air in line the following information was provided by the initial reporter: admitted to ed with few day's history of visual changes, nausea, vomiting.Found to be hypertensive (systolic 250mmhg) requiring labetolol infusion.Also found to have closed loop gastric obstruction secondary to a hiatus hernia.Underwent decompression under general anaesthesia by ogd and ng placement, uneventful.Ct head performed for neurological symptoms initially reported incidental finding of widespread intra- and extra-cranial air.Ent endoscopy nad for cause.No evidence of mediastinal or oesophageal injury as cause.Repeat opinion sought from neuroradiology, reported as: there is gas in the skull base soft tissue and also intracranial extradural compartments at the skull base and cavernous sinuses.The gas locules appear intravascular and can also be seen in the right ijv.This is likely to be due to an intravenous gas embolus.The gas has cleared by the subsequent ct angiogram performed a few hours later, which confirms this to be intravenous gas embolus.No intracranial haemorrhage or infarct.Ct head performed at 1.17am, prior to any medication administration by ed (based on epma).Single cannula in situ when arrived in anaesthetic room not of the type inserted by ed (different make).No central line in situ.Concerns include: 1.Source of air embolism - equipment failure? 2.Volume of air may have been significant (as likely more entrained than visible on ct head) with high risk of harm 3.While there was no harm apparent the risk from this volume of air was significant with the potential for severe harm.Discussed with ed and informed that cannulae in ed were changed due to concerns about air entrainment through cannulae used by ambulance service.Incident reported by (b)(6) hospitals.

Manufacturer Narrative

The reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.A complaint history record (chr) review could not be performed as no batch/lot number was made available for this reported event.A device history record (dhr) review could not be performed as no batch/lot number was made available for this reported event.

Event Description

Admitted to ed with few day's history of visual changes, nausea, vomiting.Found to be hypertensive (systolic 250mmhg) requiring labetalol infusion.Also found to have closed loop gastric obstruction secondary to a hiatus hernia.Underwent decompression under general anaesthesia by ogd and ng placement, uneventful.Ct head performed for neurological symptoms initially reported incidental finding of widespread intra- and extra-cranial air.Ent endoscopy nad for cause.No evidence of mediastinal or oesophageal injury as cause.Repeat opinion sought from neuroradiology, reported as: there is gas in the skull base soft tissue and also intracranial extradural compartments at the skull base and cavernous sinuses.The gas locules appear intravascular and can also be seen in the right ijv.This is likely to be due to an intravenous gas embolus.The gas has cleared by the subsequent ct angiogram performed a few hours later, which confirms this to be intravenous gas embolus.No intracranial haemorrhage or infarct.Ct head performed at 1.17am, prior to any medication administration by ed (based on epma).Single cannula in situ when arrived in anaesthetic room not of the type inserted by ed (different make).No central line in situ.Concerns include: 1.Source of air embolism - equipment failure? 2.Volume of air may have been significant (as likely more entrained than visible on ct head) with high risk of harm 3.While there was no harm apparent the risk from this volume of air was significant with the potential for severe harm.Discussed with ed and informed that cannulae in ed were changed due to concerns about air entrainment through cannulae used by ambulance service.Incident reported by (b)(6).

Manufacturer Narrative

Correction mdr to change f code.The reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.A complaint history record (chr) review could not be performed as no batch/lot number was made available for this reported event.A device history record (dhr) review could not be performed as no batch/lot number was made available for this reported event.H3 other text : see h10 manufacture narrative.

Event Description

Admitted to ed with few day's history of visual changes, nausea, vomiting.Found to be hypertensive (systolic 250mmhg) requiring labetolol infusion.Also found to have closed loop gastric obstruction secondary to a hiatus hernia.Underwent decompression under general anaesthesia by ogd and ng placement, uneventful.Ct head performed for neurological symptoms initially reported incidental finding of widespread intra- and extra-cranial air.Ent endoscopy nad for cause.No evidence of mediastinal or oesophageal injury as cause.Repeat opinion sought from neuroradiology, reported as: there is gas in the skull base soft tissue and also intracranial extradural compartments at the skull base and cavernous sinuses.The gas locules appear intravascular and can also be seen in the right ijv.This is likely to be due to an intravenous gas embolus.The gas has cleared by the subsequent ct angiogram performed a few hours later, which confirms this to be intravenous gas embolus.No intracranial haemorrhage or infarct.Ct head performed at 1.17am, prior to any medication administration by ed (based on epma).Single cannula in situ when arrived in anaesthetic room not of the type inserted by ed (different make).No central line in situ.Concerns include: 1.Source of air embolism - equipment failure? 2.Volume of air may have been significant (as likely more entrained than visible on ct head) with high risk of harm.3.While there was no harm apparent the risk from this volume of air was significant with the potential for severe harm.Discussed with ed and informed that cannulae in ed were changed due to concerns about air entrainment through cannulae used by ambulance service.Incident reported by (b)(6).

• Brand Name: BD VENFLON PRO SAFETY 18GA 1.3MM OD 45MM L
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18876211
• MDR Text Key: 337739747
• Report Number: 2243072-2024-00267
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 393227
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 04/11/2024; 04/25/2024
• Supplement Dates FDA Received: 04/15/2024; 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1