C.R. BARD, INC. (COVINGTON) -1018233 BULB TYPE IRRIGATION SYRINGE 50ML, PLASTIC STERILE
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Model Number 0035280 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Event Description
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It was reported that foreign material was found inside the syringe.
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Event Description
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It was reported that foreign material was found inside the syringe.Per follow up via ibc on 18mar2021, the issue was found upon opening of the package.
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Manufacturer Narrative
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The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was not used for treatment.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone irrigation bulb syringe.Visual inspection of the sample noted no obvious visible defects.It was noted that there was a loose piece of cardboard material on the interior of the syringe barrel.This does not meet product specifications.A potential root cause for this failure could be "no following to production areas cleaning procedure".The dhr review could not be performed without a lot number.A labeling review was not performed because labelling could not have prevented the reported failure.H11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was evaluated.
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