C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM; BALLOON FLOW-ASSISTED BIPOLAR ELECTRODE CATHETER
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Model Number 006173P |
Device Problems
Burst Container or Vessel (1074); Gas/Air Leak (2946)
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Patient Problems
Exposure to Body Fluids (1745); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/22/2022 |
Event Type
Injury
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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 leaked air.Also stated that the patient exposed to hazardous, blood, or bodily fluids.
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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.H11: section a through f - the information provided by bd represents all 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 leaked air.Also stated that the patient exposed to hazardous, blood, or bodily fluids.It was unknown what medical intervention was given.
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Manufacturer Narrative
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The reported event was confirmed and the cause was unknown.Although a specific cause could not be determined, a potential root cause for this event could be, "contaminants, latex defects or abrasion of balloon after attachment to shaft, windows or inclusions over stretched balloon".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "do not inflate balloon beyond stated maximum inflation capacity of 1.5 ml." "if the balloon catheter has been inflated in vivo for more than one minute, completely deflate the balloon and reinflate it to the recommended capacity of 1.5 ml.This is recommended because carbon dioxide diffuses through the latex balloon." "inspection instructions 1.Inspect the sterile package carefully for damage during transit or storage.Do not use the catheter if the package is damaged.2.Visually inspect the catheter, under sterile conditions, for kinks in the catheter shaft, integrity of the connector, condition of electrodes, and any other damage.3.In case of catheters with a balloon, under sterile conditions, remove the protective sheath and inflate the balloon with 1.5 ml of air or carbon dioxide.Use the inflation syringe included in the package.Completely deflate the balloon after the test." h11: section a through f - 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.H3 other text : the actual/suspected device was inspected.
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Event Description
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It was reported that the balloon leaked air.Also stated that the patient exposed to hazardous, blood, or bodily fluids.It was unknown what medical intervention was given.
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Search Alerts/Recalls
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