Model Number 382523 |
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.Medical device expiration date: unknown.Device manufacture date: unknown.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 the bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 20ga 1.00in during use cause blood clots.The following information was provided by the initial reporter: material no.: 382523, batch no.: unknown.Verbatim: ¿it was reported that a mckesson rep called and left a voicemail stating that the autoguard catheter # 382523 has caused blood clots on 2 different patients.".
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Event Description
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It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 20ga 1.00in during use cause blood clots.The following information was provided by the initial reporter: material no.: 382523; batch no.: unknown.Verbatim: ¿it was reported that that a mckesson rep called and lefft a voicemail stating that the autoguard catheter # 382523 has caused 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.H3 other text : see h.10.
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Search Alerts/Recalls
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