C.R. BARD, INC. (BASD) -3006260740 PINPOINT GELCAP, WO GUIDE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number N/A |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/20/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of hufs0829 showed no other similar product complaint(s) from this lot number.
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Event Description
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It was reported "when customer went to use gel caps for prevue, one package was opened and black dots which looked like mold were inside the gel caps." no other information was provided.
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Manufacturer Narrative
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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.The initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had not occurred.The samples were analyzed using optical microscopy and scanning electron microscopy (sem) with energy dispersive spectroscopy (eds).Sem images did not show any structures, such as spores to indicate mold.
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Event Description
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It was reported "when customer went to use gel caps for prevue, one package was opened and black dots which looked like mold were inside the gel caps." no other information was provided.
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Search Alerts/Recalls
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