Catalog Number 393224 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/09/2023 |
Event Type
malfunction
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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 that the bd venflon¿ pro safety peripheral safety iv catheter had dirt in it.The following information was provided by the initial reporter: "this is associated with dirt and a considerable risk of infection for staff, patients and cleaning staff.".
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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: 16-feb-2023.H6: investigation summary: our quality engineer inspected the 4 photos, 1 venflon pro safety sample and 1 sarstedt adapter sample submitted for evaluation.An evaluation was only performed on the 4 photos and the 1 venflon pro safety sample returned.Bd cannot perform an investigation of a non-bd device.The reported issues of foreign matter were not confirmed upon inspection and testing of the samples.Analysis of the venflon pro safety sample showed that there was foreign matter observed.Connection between the two returned samples was also tested and no issues were observed.Bd cannot determine a manufacturing related root cause since the defects were not confirmed.
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Event Description
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It was reported that the bd venflon¿ pro safety peripheral safety iv catheter had dirt in it.The following information was provided by the initial reporter: "this is associated with dirt and a considerable risk of infection for staff, patients and cleaning staff.".
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Search Alerts/Recalls
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