Catalog Number 260100B |
Device Problems
Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.
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Event Description
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Material no: 260100b, batch no: 1187812.It was reported that applicators in packaged affected materials are dry.Verbatim: 2879 ea.Of part number cs260100b- bd # 260100b has been rejected by our plant because the material inside the package is dry.The applicator originally comes impregned by a solution, but this affected material is dry.
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Event Description
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Material no: 260100b, batch no: 1187812.It was reported that applicators in packaged affected materials are dry.Verbatim: 2879 ea.Of part number cs260100b- bd # 260100b has been rejected by our plant because the material inside the package is dry.The applicator originally comes impregned by a solution, but this affected material is dry.Video and information.Part number: cs260100b; lot number: 1187812; po: (b)(4); qty: (b)(4); unit cost: (b)(4); total cost: (b)(4); total $ (b)(4).Please let us know how to disposition this product with a cod and credit or provide a return authorization for this discrepant material.Per email: i send this email to notify that (b)(4) ea.Of part number cs260100b has been rejected by our plant because the material inside the package is dry.The applicator originally comes impregned by a solution, but this affected material is dry.Video and information: part number: cs260100b; lot number: 1187812; po: (b)(4); qty: (b)(4); unit cost: (b)(4); total cost: $ (b)(4); total $ (b)(4).Please reach to the supplier to get a disposition for this discrepant material.
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Manufacturer Narrative
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Please note that the annex a code was entered incorrectly on the initial mdr, this supplemental holds the correct a codes a0203 - defective device (2588) the root cause can be attributed to our equipment as the solution ran low on the thank during fill.We have taken corrective actions such as training technicians and assembly associates about this failure mode and how to correct the failure if it were to occur again.Production batch history records for applicator pn (b)(4) lot number 1187812 were reviewed and a bounding was reported for missing solution defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see below.
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Search Alerts/Recalls
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