Catalog Number 930815 |
Device Problems
Product Quality Problem (1506); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) initial mdr.A follow up will be submitted if additional information becomes available.
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Event Description
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It was reported by the sales representative that there was no dye in the applicator.
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Event Description
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Material no.: 930815 batch no.: 1089896 it was reported by the sales representative that there was no dye in the applicator.Per complaint form: a staff member turned in a chloraprep because when they went to use it there was no orange dye, but just the liquid came out.
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Manufacturer Narrative
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Photos were provided and bd was able to confirm the failure mode.The batch record for pn 930815 ln 1089896 was reviewed and there were no non-conformances related to "missing pledget" during the manufacturing of this lot.Furthermore, the maintenance logbook was reviewed as well and there were no issues reported with the function of the pledget presence sensor during the manufacturing of the lot.It is most probable that the sensor did not function correctly and failed to alert the absence of the pledget in the applicator.
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Search Alerts/Recalls
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