Catalog Number 394601 |
Device Problems
Disconnection (1171); Leak/Splash (1354)
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Patient Problems
Hemorrhage/Bleeding (1888); Insufficient Information (4580)
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Event Date 09/20/2021 |
Event Type
Injury
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Manufacturer Narrative
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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 when using the bd connecta¿ multiflo¿ 3-way multiple infusion manifold, the device experienced a loose connection / separation which caused a leak.The following information was provided by the initial reporter.The customer stated: yesterday afternoon we met with the head of anaesthesia and intensive care, who quickly explained the dynamics of the accident as he was busy in the operating room: the tap was connected to a bd venflon pro safety cannula needle, the limb covered by a drape and out of sight.The tap had become disconnected from the cannula needle, resulting in significant blood loss and interruption of infusions.They only noticed the leak when the patient lost a considerable amount of blood as the drape placed under the patient absorbed the blood loss.He will shortly send a detailed report of the incident, which the pharmacy will forward to the health department and to us.The actions that will be immediately taken by the facility are the definitive suspension of the use of the connecta tap, which already has shown in other situations frequent leaks from the luer lock/needle cannula connection.I will replace the connecta with sendal taps (which they will evaluate) and with taps with extension which they suggested as the best solution.As soon as i have a copy of the report i will complete the information about the patient's condition and the connective actions taken on the patient.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-11-01.H6: investigation summary: our quality engineer inspected the 3 packaged samples and 1 unpacked sample submitted for evaluation.The reported issue was not confirmed upon inspection and testing of the samples.During the visual examination of the samples no damages were observed on the samples.The 4 samples were also tested for leakage using our internal methods and none of the samples exhibited leakage.Since bd could not confirm the defect, a manufacturing root cause could not be determined.A device history record review showed no non-conformances associated with this issue during the production of this batch.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.H3 other text : see h10.
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Event Description
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It was reported when using the bd connecta¿ multiflo¿ 3-way multiple infusion manifold, the device experienced a loose connection / separation which caused a leak.The following information was provided by the initial reporter.The customer stated: yesterday afternoon we met with the head of anaesthesia and intensive care, who quickly explained the dynamics of the accident as he was busy in the operating room: the tap was connected to a bd venflon pro safety cannula needle, the limb covered by a drape and out of sight.The tap had become disconnected from the cannula needle, resulting in significant blood loss and interruption of infusions.They only noticed the leak when the patient lost a considerable amount of blood as the drape placed under the patient absorbed the blood loss.He will shortly send a detailed report of the incident, which the pharmacy will forward to the health department and to us.The actions that will be immediately taken by the facility are the definitive suspension of the use of the connecta tap, which already has shown in other situations frequent leaks from the luer lock/needle cannula connection i will replace the connecta with sendal taps (which they will evaluate) and with taps with extension which they suggested as the best solution.As soon as i have a copy of the report i will complete the information about the patien's condition and the connective actions taken on the patient.
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Search Alerts/Recalls
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