Catalog Number 0935280 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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.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.The device was not returned.
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Event Description
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It was reported that the bulb syringe allegedly had what appeared to be dirt inside of it.Additional information has been requested and not yet received.
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Manufacturer Narrative
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Received 1 surgical syringe only.The reported event was confirmed as cause unknown.During the visual inspection, it was noted that the sample had foreign material in the bulb neck.It was measured and the following results were obtained: foreign material = 0.250 in (specification is loose or embedded foreign matter greater than 0.6mm2 or 1/16¿ in length is not permitted.(3 particles maximum per side or surface).In order to verify if the foreign material was embedded, the following task was performed: take a towel and wet it with alcohol.Wipe the bulb with towel.During this task the foreign material was removed.The foreign material is loose.The foreign material exceeded its specification.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "irrigation syringe bulb type non sterile" (b)(4).
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Event Description
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It was reported that the bulb syringe allegedly had what appeared to be dirt inside of it.Additional information has been requested and not yet received.
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Search Alerts/Recalls
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