C.R. BARD, INC. (COVINGTON) -1018233 RELIAVAC 400 EVACUATOR, 400ML CAPACITY, Y-CONNECTING TUBE, 35" (88.9CM) STERILE; SUCTION EVACUATOR
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Model Number 0070800 |
Device Problems
Incorrect Measurement (1383); Material Rupture (1546)
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Patient Problems
No Consequences Or Impact To Patient (2199); Insufficient Information (4580)
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Event Date 08/07/2020 |
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 the balloon burst on the 6th day of use.Per additional information received from ibc via mail on 02sep2020, the balloon burst in the bottle.
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Manufacturer Narrative
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The reported event was confirmed as manufacturing-related.An evacuator was returned without its original packaging.The balloon was found to be burst.On (b)(6) 2020, the balloon was obtained to measure the thickness of the portions of the balloon that burst to determine if there was a manufacturing defect.Measurement varied from 0.0485"-0.0640".As there were measurements were found above 0.058" the device was found to fail specifications.A potential root cause could be due to an "operator error" during the latex dipping.The lot number was unknown; therefore, the device history record could not be reviewed.As the reported event was confirmed as manufacturing related, a labeling review was not performed.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.
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Event Description
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It was reported that the balloon burst on the 6th day of use.Per additional information received from ibc via mail on 02sep2020, the balloon burst in the bottle.
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Search Alerts/Recalls
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