Catalog Number 393229 |
Device Problem
Leak/Splash (1354)
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Patient Problems
Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)
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Event Date 04/09/2021 |
Event Type
Death
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Manufacturer Narrative
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Initial reporter phone #: (b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the bd venflon" pro safety shielded iv catheter experienced leakage from the injection port, and was involved with a patient death.The patient had extremely low blood pressure, and went into peri-cardiac arrest.The patient could not be resuscitated due to the device failure.Surgical intervention was administered, and under continually unstable conditions, the patient died post-operatively.The following information was provided by the initial reporter: i have had a complaint from the following customer in respect to a 16g venflon pro safety catheter.She advised that it was a very serious incident i have no further details as it was a very brief conversation but she confirmed she would send further details but i wanted to ensure that this was logged.It was a 16 g pro safety cannula sited anterior chest wall due to very poor vascular access.We have had many similar incidents with the pro safety cannulas recently and this follows the same pattern.Unstable patient needing general anaesthesia (ga) to repair bleeding abdominal aortic aneurysm.Last of ga drugs injected into top of cannula and pop felt and fluid poured out of the top of the cannula.This cannula was connected to a rapid infuser which was primed with blood products.A cannula cap was put on top of the cannula but popped off.Therefore a smartsite was screwed into the cannula port to stem the flow of fluid and drugs out of the cannula but this resulted in cannula occlusion and failure of rapid infuser back pressure caused fluids to pour out of reservoir.Infuser unable to be used and primed blood products were discarded 2 units of packed red cells and 2 units of ffp.Consultant anaesthetist aware of cannula problems due to eo sterilization but due to urgency of situation the nearest cannula was used.Decision not to use 3-way tap as fluids were being bolused in simultaneously to resuscitate patient.Patient peri-cardiac arrest after this systolic bp 40mmhg.18g cannula inserted and patient received iv adrenaline to resuscitate.Surgery was undertaken patient continued to be very unstable and died post-operatively.Has there been any serious injury? as above patient had extremely low blood pressure peri-cardiac arrest.Resuscitation could not continue due to failure of cannula.
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Manufacturer Narrative
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H.6.Investigation: no photos or samples were received by our quality team for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the verbatim from the customer, the probable root cause for the leakage is most likely to be related to the modification in the injection port valve dimensions to accommodate ethylene oxide (eto) sterilization.A field safety notice has been issued on the possible clinical impact and advice for clinical users.Capa#: 1379444 was initiated.
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Event Description
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It was reported that the bd venflon¿ pro safety shielded iv catheter experienced leakage from the injection port, and was involved with a patient death.The patient had extremely low blood pressure, and went into peri-cardiac arrest.The patient could not be resuscitated due to the device failure.Surgical intervention was administered, and under continually unstable conditions, the patient died post-operatively.The following information was provided by the initial reporter: i have had a complaint from the following customer in respect to a 16g venflon pro safety catheter.She advised that it was ¿a very serious incident¿ i have no further details as it was a very brief conversation but she confirmed she would send further details but i wanted to ensure that this was logged.It was a 16 g pro safety cannula sited anterior chest wall due to very poor vascular access.We have had many similar incidents with the pro safety cannulas recently and this follows the same pattern.Unstable patient needing general anaesthesia (ga) to repair bleeding abdominal aortic aneurysm.Last of ga drugs injected into top of cannula and pop felt and fluid poured out of the top of the cannula.This cannula was connected to a rapid infuser which was primed with blood products.A cannula cap was put on top of the cannula but popped off.Therefore a smartsite was screwed into the cannula port to stem the flow of fluid and drugs out of the cannula but this resulted in cannula occlusion and failure of rapid infuser back pressure caused fluids to pour out of reservoir.Infuser unable to be used and primed blood products were discarded 2 units of packed red cells and 2 units of ffp.Consultant anaesthetist aware of cannula problems due to eo sterilization but due to urgency of situation the nearest cannula was used.Decision not to use 3-way tap as fluids were being bolused in simultaneously to resuscitate patient.Patient peri-cardiac arrest after this systolic bp 40mmhg.18g cannula inserted and patient received iv adrenaline to resuscitate.Surgery was undertaken patient continued to be very unstable and died post-operatively.Has there been any serious injury? as above patient had extremely low blood pressure peri-cardiac arrest.Resuscitation could not continue due to failure of cannula.
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Search Alerts/Recalls
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