Catalog Number 385110 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/07/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 a luer-lock product was mixed into the carton of bd¿ prn adapters.The following information was provided by the initial reporter, translated from (b)(6): "this is a report about a mixed product.The customer reported as follows: in a carton of prn luer slip adapter (cat#385110; lot#0230628), one luer lock product was found.This complaint product was placed in the package with the product information of cat#385110 and lot#1194667.".
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Manufacturer Narrative
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H.6: investigation summary: in response to the event reported by your facility a device history review was conducted for lot number 0230628.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.Additionally, a photograph of the reported issue was submitted to aid in our investigation.Our engineers noted that the photograph displayed an opened luer-slip packaging unit and a luer-lock device.During the review of the manufacturing records for both lots , our engineers were able to identify a one-year difference in production dates between these two lots with lot#0230628 being manufactured in september of 2020 and lot#1194667 being manufactured in august of 2021.Similarly the shipment dates of these two lots was separated by one-year.Based on this information our engineers could not determine a production related root cause for the inclusion of the later lot#1194667 in the carton of the earlier lot#0230628, as they could not rule out a mix-up after the product had left the facility.As a precautionary measure we have issued a retrain to our production team to increase awareness of this potential issue.H3 other text : see h.10.
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Event Description
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It was reported that a luer-lock product was mixed into the carton of bd¿ prn adapters.The following information was provided by the initial reporter, translated from japanese: "this is a report about a mixed product.The customer reported as follows: in a carton of prn luer slip adapter (cat#385110; lot#0230628), one luer lock product was found.This complaint product was placed in the package with the product information of cat#385110 and lot#1194667.".
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Search Alerts/Recalls
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