Catalog Number 257306 |
Device Problem
Contamination of Device Ingredient or Reagent (2901)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/10/2022 |
Event Type
malfunction
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Event Description
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It has been reported that the bd¿ columbia cna agar with 5% sheep blood has been found experiencing 60 occurrences of contamination.The following has been provided by the initial reporter: half of the plates are contaminated.Customer said that half of the plates (they have 2 cases of 120 with this lot) are contaminated.
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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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Family (b)(6) (b)(6) - pr# (b)(4), biological contamination.Division / project: business process / mdr created: (b)(6) 2022 10:30 am.Save.Save & exit.Cancel.New.Copy.Child.Check spelling.Workflow.Pending successful ack3 submission accepted in state for 29 days.Activity type.Enter your selection here.Date scheduled.Calendar.Now.Person responsible.Search.Date performed.Calendar.Now.Show all fields.Mdr ownership.Patient information (a).Adverse event or prod prob (b).Suspect products (c).Suspect medical device (d).Med device reprocess info (d).Initial reporter (e).User facility / importer (f).All manufacturers (g).Device manufacturers only (h).Approvals and acknowledgements.Supporting documents and notes.Hidden fields.Adverse type.Product problem.Date of event.2022-03-10.Event attributed to.If you select other - please explain in field "other details".Death? no.Date of death.Other details.If event attributed to has been populated as other enter the details here - otherwise enter 'n/a" here.Na.Describe event or problem maximize.It has been reported that the bd¿ columbia cna agar with 5% sheep blood has been found experiencing 60 occurrences of contamination.The following has been provided by the initial reporter: half of the plates are contaminated.Customer said that half of the plates (they have (b)(4) with this lot) are contaminated.Relevant tests/laboratory data maximize.None reported.Other relevant history maximize.
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Manufacturer Narrative
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Investigation summary: it was reported that (b)(4) plates would have show contamination.The complaint trends were reviewed and similar complaints were found for this lot number.Therefore, a mrb (material review board) was performed and this issue will be investigated within a capa (corrective and preventive action) (b)(4).The batch history review did not indicate any discrepancies.All release testing was satisfactory, and no deviations were observed.Pictures were provided showing the reported contamination.The retention samples were reviewed and the plates were found to be without deviation.At this stage of our investigation, we have excluded any systemic failure in our manufacturing process.Please note that this product does not have an sal claim.It is filled aseptically, therefore an occurrence of a contamination event cannot be entirely ruled out.We only release product batches to the market with an aql (acceptable quality level) = 1.5.Although this contamination level is very low, we cannot completely exclude that a customer may receive a contaminated plate.As several complaints were reported for this product lot number regarding contamination, a mrb (mrb 22-006) and capa (# 4344556) were created for further evaluation.The root cause investigation is currently ongoing within capa 4344556.Based upon our investigation the complaint was confirmed.
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Search Alerts/Recalls
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