Catalog Number 0038460 |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/11/2016 |
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.
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Event Description
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It was reported that the toomey adaptor allegedly does not fit properly into the toomey syringe.The toomey adapter allegedly falls off during intra-op.The toomey syringe was being used to irrigate the bladder during a transurethral resection of the prostate (turp) procedure.
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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.
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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.
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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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Manufacturer Narrative
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The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: "three syringe tips are intended for use as follows: integral toomey tip - resectoscope irrigation, catheter tip - for catheter irrigation, 1 luer adapter (for foley catheter inflation).Warning: reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Caution: secure tip tightly prior to use.Caution: avoid excessive syringe pressure when using luer adapter, as the adapter may dislodge." (b)(4).
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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