Catalog Number 0038460 |
Device Problems
Loose or Intermittent Connection (1371); Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/16/2016 |
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 dr.(b)(6) was using the toomey and tried to connect a device to the toomey as he has in the past, however, it was allegedly loose.The apparent loose state meant that the toomey could not be used as a suction device.The nurses tried several other toomeys but allege the same thing happened.The rep, (b)(4), also tried three different toomeys and found the same thing.The toomey syringe was allegedly being used during a turp procedure to suction out chips from the prostate.
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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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Received 3 unopened toomey syringes in the original unit packaging of the same lot.During the visual inspection no obvious defects were noted in the samples.Functional evaluation was performed, in order to verify the function of the samples the following task were performed: fill the syringe with 70cc water.Hold the syringe.During this test detected that the syringes did not hold the water.The plunger slipper through the barrel itself.Dimensional evaluation found the plunger tip out of specification in all samples.The reported event is confirmed as supplier related.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instruction 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)." (b)(4).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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