Catalog Number 0250070500 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/04/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that a big part of the bottle's seal was broken at the insertion of the spike.This went into the bottle and was inside the patient.The surgeon was able to retrieved the whole thing back.Although there was patient involvement, there was no patient impact and no adverse consequences.
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Manufacturer Narrative
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The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is received, the complaint will be reopened and the investigation will be updated with the new results.Probable root cause for the reported failure involving this device could have been caused by: 1.Material/design error, 2.Manufacturing/assembly error, 3.Improper cleaning/sterilization, 4.Excessive user force, 5.Severe shipping conditions, 6.Disposable tip rubbing against lid, 7.User misuse.
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Event Description
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It was reported that a big part of the bottle's seal was broken at the insertion of the spike.This went into the bottle and was inside the patient.The surgeon was able to retrieved the whole thing back.Although there was patient involvement, there was no patient impact and no adverse consequences.
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Manufacturer Narrative
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(b)(4).The product was returned and the failure mode was confirmed.The two tubesets were visually inspected for damages, and the distal tips of the insertion spikes are bent.The probable root causes could be: material/design error.Manufacturing/assembly error.Improper cleaning/sterilization.Excessive user force.Severe shipping conditions.Disposable tip rubbing against product.User misuse.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that a big part of the bottle's seal was broken at the insertion of the spike.This went into the bottle and was inside the patient.The surgeon was able to retrieved the whole thing back.Although there was patient involvement, there was no patient impact and no adverse consequences.
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Search Alerts/Recalls
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