Catalog Number 515302 |
Device Problems
Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturing location for this product is cazin, bosnia.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.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 3 bd phaseal¿ secondary sets c61 had damaged tubing that was sliced open through the packaging.The following information was provided by the initial reporter: "3 units of c61 were sliced due to packaging error.".
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Event Description
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It was reported that 3 bd phaseal¿ secondary sets c61 had damaged tubing that was sliced open through the packaging.The following information was provided by the initial reporter: "3 units of c61 were sliced due to packaging error.".
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Manufacturer Narrative
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H6: investigation summary: a device history review was conducted for lot number 1022262.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.During examination of retain samples, no defect has been noticed.Sample have no issues.Additionally a photograph was provided which displayed a sealed empty packaging unit.The issue has been confirmed.Based on the image our engineers were able to directly associated this issue with the manual packaging process.To prevent future occurrences the appropriate personnel have been notified of this event.
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Search Alerts/Recalls
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