C.R. BARD, INC. (COVINGTON) -1018233 BARD PISTON IRRIGATION TRAY WITH 70ML PISTON SYRINGE; IRRI TRAY PISTN SYRINGE
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Catalog Number 750307 |
Device Problem
Inability to Irrigate (1337)
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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.
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Event Description
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It was reported that the irrigation syringes were not holding a seal, so when trying to draw up volume to irrigate, irrigation fluid just poured back out.Health professionals were not able to fill the syringe, which was necessary to effectively irrigate a bladder.Four different irrigation syringes were tried, all with the same result and all with the same lot number.Per complainant statement, it significantly affected patient care over approximately 20 hours.Night shift was unable to properly irrigate the clots, which required a foley catheter replacement.The patient was scheduled for surgery the next morning.After surgery, day shift was unable to properly irrigate the foley when it became clotted again, so it was again exchanged.
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Manufacturer Narrative
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Upon further review, bard/bd has determined that this mdr was reported in error as this event is not reportable.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 irrigation syringes were not holding a seal, so when trying to draw up volume to irrigate, irrigation fluid just poured back out.Health professionals were not able to fill the syringe, which was necessary to effectively irrigate a bladder.Four different irrigation syringes were tried, all with the same result and all with the same lot number.Per complainant statement, it significantly affected patient care over approximately 20 hours.Night shift was unable to properly irrigate the clots, which required a foley catheter replacement.The patient was scheduled for surgery the next morning.After surgery, day shift was unable to properly irrigate the foley when it became clotted again, so it was again exchanged.
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Search Alerts/Recalls
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