Catalog Number 515316 |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.
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Event Description
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It was reported that bd phaseal secondary set (c66) was clogged.The following information was provided by the initial reporter: "the following has been left behind for a while due to covid, but we regularly have a secondary set c66 that we cannot aspirate after connecting to the iv bag.Nothing can be pulled out of the iv bag or added to the iv bag via the connector after spiking the iv bag.I have put 1 example aside if you need this for research (but i have previously passed on this complaint i thought).The line i have kept is therefore a secondary set c66 with reference 515316, lot number ta11382 and expiry date 2022-09-30.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 7/20/2020.H.6.Investigation: one sample was returned to our quality team for investigation.Upon inspecting the product, functional testing was performed and it was verified that liquid could not pass through the filter.A device history review was performed and found no non-conformances associated with this issue during the production of lot ta11382.Four retained samples from the same lot were used for additional evaluation.In all cases the product functioned properly and no issues related to flow were identified.After further evaluation of the returned sample, the filter line was identified to be obstructed.This component is provided by an external supplier whom we have notified of this incident.Through their investigation they observed the port was blocked.A review of the device records for the impacted component did not reveal any non-conformities related to this failure.A direct issue could not be identified.H3 other text : see h.10.
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Event Description
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It was reported that bd phaseal secondary set (c66) was clogged.The following information was provided by the initial reporter: "the following has been left behind for a while due to covid, but we regularly have a secondary set c66 that we cannot aspirate after connecting to the iv bag.Nothing can be pulled out of the iv bag or added to the iv bag via the connector after spiking the iv bag.I have put 1 example aside if you need this for research (but i have previously passed on this complaint i thought).The line i have kept is therefore a secondary set c66 with reference 515316, lot number ta11382 and expiry date 2022-09-30.".
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Search Alerts/Recalls
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