Catalog Number 212354 |
Device Problem
Leak/Splash (1354)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that sample leakage occurred with the bd bbl¿ vitamin k1 - hemin solution prior to use.There was no report of patient impact.The following information was provided by the initial reporter: the product was returned.The outer was dry looking but when opened the content was spilled.
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Manufacturer Narrative
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H6: after further evaluation of the complaint, it has been determined that the previously submitted mfr report# 1119779-2021-00163 was sent in error.This complaint is not mdr reportable.There was no report of serious injury, medical intervention, or reportable.This particular event would require the user to acquire replacement material in order to use as intended.This event results in user dissatisfaction.These physical defects do not negatively affect the results, and would render the product unusable.This is unlikely to cause serious injury.
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Event Description
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It was reported that sample leakage occurred with the bd bbl¿ vitamin k1 - hemin solution prior to use.There was no report of patient impact.The following information was provided by the initial reporter: the product was returned.The outer was dry looking but when opened the content was spilled.
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Search Alerts/Recalls
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