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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Event Description
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It was reported via phone call "upon opening the package, there is mold in the gel caps".No other information was provided.
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Manufacturer Narrative
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The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of hufr0001 showed seventy-five other similar product complaint(s) from this lot number.
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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 via phone call "upon opening the package, there is mold in the gel caps".No other information was provided.
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Search Alerts/Recalls
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