Catalog Number 80219 |
Device Problems
Device Markings/Labelling Problem (2911); Missing Information (4053)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/05/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The medical device manufacturer (d3) and manufacturing location for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.The catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex products that are cleared in the us.The pro code and 510 k number for the rotarex products are identified in d2 and g4.As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 07/2024).The information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Device not returned.
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Event Description
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It was reported that prior to a recanalization procedure, the ifu of the device was allegedly found to be missing.There was no patient contact.
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Manufacturer Narrative
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H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex products that are cleared in the us.The pro code and 510 k number for the rotarex products are identified in d2 and g4.H10: manufacturing review: a device history record review is not applicable because the attachment of the regional instructions for use is an outsourced process at the distribution center that takes place when the product left the production already.Investigation summary: the sample was not returned to the manufacturer for evaluation.Based on the available information, the investigation is confirmed for reported issues.The root cause is traced to labeling issue.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 07/2024).H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.
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Event Description
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It was reported that prior to a recanalization procedure, the ifu of the device was allegedly found to be missing.There was no patient contact.
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Event Description
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It was reported that prior to a recanalization procedure, the ifu of the device was allegedly found to be missing.There was no patient contact.
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Manufacturer Narrative
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H10: the initial mdr was inadvertently submitted with a g3 date of 05/04/2022.The correct g3 date is 04/05/2022.H10: manufacturing review: a device history record review is not applicable because the attachment of the regional instructions for use is an outsourced process at the distribution center that takes place when the product left the production already.Investigation summary: the sample was not returned to the manufacturer for evaluation.Based on the available information, the investigation is confirmed for reported issues.The root cause is traced to labeling issue.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex products that are cleared in the us.The pro code and 510 k number for the rotarex products are identified in d2 and g4.H10: d4 (expiry date: 07/2024).H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.
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Search Alerts/Recalls
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