Catalog Number 381434 |
Device Problems
Leak/Splash (1354); Material Separation (1562); Defective Device (2588)
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Patient Problem
No Code Available (3191)
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Event Date 07/18/2018 |
Event Type
Injury
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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 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 bd insyte¿ autoguard¿ shielded iv catheters have a defective lure lock and the ivs are pulling apart causing leakage.It was reported that patients are waking up from anesthesia and having medication interruptions.
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Event Description
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It was reported that bd insyte autoguard shielded iv catheters have a defective lure lock and the ivs are pulling apart causing leakage.It was reported that patients are waking up from anesthesia and having medication interruptions.
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Manufacturer Narrative
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No samples or photos were returned in support of this complaint.A dhr was not conducted for this investigation because a lot number was not provided for this incident.Indeterminate: units nor photos were not provided for observation and/or testing of this incident therefore the alleged defect was not identified or confirmed and a root cause was not established.Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: no.
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Manufacturer Narrative
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The following fields have been updated due to additional information: medical device lot #: 8037504, medical device expiration date: 01/31/2021, device manufacture date: 02/06/2018.Medical device lot #: 7313750, medical device expiration date: 10/31/2020, device manufacture date: 11/09/2017.Investigation: since no samples displaying the condition reported are 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 these batches.
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Event Description
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It was reported that bd insyte¿ autoguard¿ shielded iv catheters have a defective lure lock and the ivs are pulling apart causing leakage.It was reported that patients are waking up from anesthesia and having medication interruptions.
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Search Alerts/Recalls
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