Catalog Number 309571 |
Device Problem
Missing Information (4053)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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B.3.Date of event: unknown.The date received by manufacturer has been used for this field.E.1.The customer's address is unknown.Virginia, usa has been used as a placeholder based on the reported phone area code.H.3.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 3 bd luer-lok¿ syringes with attached needle had no lot/expiration date on their labeling.The following information was provided by the initial reporter: "we have received and discovered an additional three cases that did not have the secondary barcode along with the lot/expiration date on the label.".
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Manufacturer Narrative
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H6: investigation summary: one photo of a 3ml luer-lock syringe box carton was received and evaluated.The image shows two box cartons, both having box labels on the carton with one label having all applicable product information and the other label missing the secondary bar code, batch number and expiration date.The condition observed is non-conforming per product specification.Potential root cause for the label content missing defect is associated with the packaging process.As corrective actions, quality alert will be issued to manufacturing facility and re-education will be provided to all operators associated with production batch.A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.
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Event Description
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It was reported that 3 bd luer-lok¿ syringes with attached needle had no lot/expiration date on their labeling.The following information was provided by the initial reporter: "we have received and discovered an additional three cases that did not have the secondary barcode along with the lot/expiration date on the label.".
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Search Alerts/Recalls
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