Catalog Number 306594 |
Device Problem
Volume Accuracy Problem (1675)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/27/2023 |
Event Type
malfunction
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Event Description
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It was reported that bd unknown prefilled syringe is missing scale markings.The following information was provided by the initial reporter, translated from chinese to english: when the warehouse manager checked the items, he found that the syringe in the prefilled catheter irrigator did not have a scale mark.He immediately contacted the manufacturer to replace the prefilled catheter irrigator with a new one.
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Manufacturer Narrative
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The material the material number is not provided therefore the lot number 3167850 that was provided has not been found and cannot be verified.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion a supplemental report will be filed.In this mdr, bd franklin lakes, nj has been listed in sections d.3.And g.1.As the manufacturing site is unknown.
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Manufacturer Narrative
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(b)(4) follow up.A device history record review was completed by our quality engineer team for provided material number 306594 and lot number 3167850.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.
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Event Description
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No additional information received when the warehouse manager checked the items, he found that the syringe in the prefilled catheter irrigator did not have a scale mark.He immediately contacted the manufacturer to replace the prefilled catheter irrigator with a new one.
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Search Alerts/Recalls
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