Catalog Number 383912 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/06/2019 |
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.
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Event Description
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It was reported that bd pegasus¿ safety closed iv catheter system was missing label information.This was discovered before use.The following information was provided by the initial reporter: on (b)(6) 2019, during quarterly warehouse inspections, customer noticed that label content missing on the packaging.Missing information including expiration date, lot#.Unable to confirm the safety of the product.
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Event Description
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It was reported that bd pegasus¿ safety closed iv catheter system was missing label information.This was discovered before use.The following information was provided by the initial reporter: on (b)(6) 2019, during quarterly warehouse inspections, customer noticed that label content missing on the packaging.Missing information including expiration date, lot#.Unable to confirm the safety of the product.
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Manufacturer Narrative
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H.6.Investigation summary: a device history review was conducted for lot number 9077765.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue.
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Search Alerts/Recalls
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