Catalog Number TS200CS |
Device Problems
Break (1069); Tear, Rip or Hole in Device Packaging (2385)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Event Description
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It was reported that the seed canister's seal was broken.None of the seeds were missing.
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d1, d4, g5.H11:section a through f - the information provided by bd represents all of 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.
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Event Description
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It was reported that the seed canister's seal was broken.None of the seeds were missing.
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Manufacturer Narrative
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This complaint was confirmed, and the root cause is undetermined.The photo provided by the customer depicted a shielded container with a broken tamper evident seal across the seam, where the lid and bottom pieces were secured together (screwed together).It is unknown when and how the tamper evident seal was broken.The reported product code doesn't have a designated lot number.As such, a device history record review was not performed.The instructions for use were found adequate and state the following: "void if broken." correction: d4 h11:section a through f - the information provided by bd represents all of 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.
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Event Description
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It was reported that the seed canister's seal was broken.None of the seeds were missing.
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Search Alerts/Recalls
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