Catalog Number 393224 |
Device Problem
Leak/Splash (1354)
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Patient Problems
Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)
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Event Date 05/06/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the bd venflon¿ pro safety peripheral safety iv catheter separated from the mating component during use on a patient.The patient was found with the cannula still in their arm and the left side of their body "covered in blood and clots", with a mixture of fluid and blood on the floor surrounding the bed.The patient was "very drowsy" and "hypotensive", with blood pressure at "50/20" as a result of the catheter separation and leakage."2 units of o neg and 2 units of ffp" were required and transfused to the patient, who was also put on a "high dependency unit" of care.The following information was provided by the initial reporter: "the patient was found with bung disconnected from the cannula in his arm and the left side of his body was covered in blood and clots, a mixture of fluid and blood was on the floor surrounding the bedside." "the patient was very drowsy, noted to be hypotensive.Bp was 50/20, patient required transfusion of 2 units of o neg and 2 units of ffp and care on high dependency unit.".
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Event Description
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It was reported that the bd venflon¿ pro safety peripheral safety iv catheter separated from the mating component during use on a patient.The patient was found with the cannula still in their arm and the left side of their body "covered in blood and clots", with a mixture of fluid and blood on the floor surrounding the bed.The patient was "very drowsy" and "hypotensive", with blood pressure at "50/20" as a result of the catheter separation and leakage."2 units of o neg and 2 units of ffp" were required and transfused to the patient, who was also put on a "high dependency unit" of care.The following information was provided by the initial reporter: "the patient was found with bung disconnected from the cannula in his arm and the left side of his body was covered in blood and clots, a mixture of fluid and blood was on the floor surrounding the bedside." "the patient was very drowsy, noted to be hypotensive.Bp was 50/20, patient required transfusion of 2 units of o neg and 2 units of ffp and care on high dependency unit.".
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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 the failure mode could not be verified and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.H3 other text : see h.10.
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Search Alerts/Recalls
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