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Catalog Number H93829 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported an unspecified quantity of luer lock universal spike was contaminated.It was further specified that the packaging was wet.This issues was identified during setup and preparation there was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Correction to the previously submitted d4:lot #, expiration date and unique identifier (udi) #.D4: lot #: 60229365 previously submitted 60232935.D4: expiration date: 01/31/2023 previously submitted 02/28/2023.D4: unique identifier (udi) #: (b)(4) previously submitted (b)(4).H10: three (3) actual samples were received for evaluation.Unaided visual inspection was performed which observed contaminated dark/transparent areas of the primary packaging on the back side and seen through on the front side of all samples.The cause of the condition was not determined.Functional testing was not performed for this complaint.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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