Model Number 382533 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombus (2101)
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Event Date 01/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter caused blood clots.This was discovered during use.The following information was provided by the initial reporter: material no.: 382523, batch no.: 8262697.It was reported that a mckesson rep called and left a voicemail stating that the autoguard catheter has caused blood clots on 2 different patients.Per email: we received a voicemail stating that the autoguard catheter has cause blood clots on 2 different patients.
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Manufacturer Narrative
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H.6.Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaint could not be confirmed and root cause is undetermined.
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Event Description
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It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter caused blood clots.This was discovered during use.The following information was provided by the initial reporter: material no.: 382523 batch no.: 8262697 it was reported that that a mckesson rep called and left a voicemail stating that the autoguard catheter has caused blood clots on 2 different patients.Per email: we received a voicemail stating that the autoguard catheter has cause blood clots on 2 different patients.
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Search Alerts/Recalls
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