Catalog Number 300450 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Oem manufacture: the manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.The date received by manufacturer has been used for this field.Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that 18 sharps coll canada 3.0l yellow experienced no lids.The following information was provided by the initial reporter: material no.: 300450, batch no.: 0062912.It was reported that the collectors were recieved without lids.
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Event Description
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It was reported that 18 sharps coll canada 3.0l yellow experienced no lids.The following information was provided by the initial reporter: material no.: 300450, batch no.: 0062912.It was reported that the collectors were "received" without lids.
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Manufacturer Narrative
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H6: investigation summary: no actual product or photo representation was provided.A review of the device history record (dhr) for the reported lot was performed and there were no issues found for missing lids during the manufacturing process of the reported lot.A review of non-conforming material report (ncmr) was performed for the last twelve months and did not identify any nonconformance.As corrective action a weighing system has already been implemented for this container manufacturing process to ensure the correct quantity of pieces per box before shipping.The root cause is unknown.The issue most likely occurred during fulfillment when repackaged for distribution.This complaint may have occurred from partial sales sold by a distributor.Additional information is needed about the handling and storage by the distributor facility to rule out that the issue was not due to incorrect handling or a partial sale.Based on these findings, our investigation is inconclusive.Evidence of original packaging is required.Bd will continue to monitor for any trends.
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Search Alerts/Recalls
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