Catalog Number 382923 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/08/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter e-mail: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that a hole was found in the paper side of the bd insyte¿ autoguard¿ bc winged shielded iv catheter unit package.The following information was provided by the initial reporter, translated from japanese: "this is a report about a damaged package of iagbc.According to the customer's report, a hole was found on the paper side of the package.".
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Event Description
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It was reported that a hole was found in the paper side of the bd insyte¿ autoguard¿ bc winged shielded iv catheter unit package.The following information was provided by the initial reporter, translated from japanese: "this is a report about a damaged package of iagbc.According to the customer's report, a hole was found on the paper side of the package.".
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Manufacturer Narrative
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H.6.Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
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Search Alerts/Recalls
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