C.R. BARD, INC. (COVINGTON) -1018233 STATLOCK SL FOLEY, UNKNOWN CODE; UNKNOWN STATLOCK DEVICE
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Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/03/2023 |
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.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.H3 other text : the device was not returned.
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Event Description
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It was reported that the statlock would not lock/click close over foley.They had replaced in emergency department & office with same issue.Representative explained that bd had 3 types of statlock foleys, one designed for latex foley catheters, one for silicone foley catheters and one universal that should fit both, if they were using a statlock for a material that was not designed then the statlock may not fit.
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Event Description
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It was reported that the statlock would not lock/click close over foley.They had replaced in emergency department & office with same issue.Representative explained that bd had 3 types of statlock foleys, one designed for latex foley catheters, one for silicone foley catheters and one universal that should fit both, if they were using a statlock for a material that was not designed then the statlock may not fit.Per follow up via phone on (b)(6) 2023, it was reported that they had an intermittent catheter in for 10 days, and the several statlocks they used would fall off completely if any tension came to the statlocks.They spoke with urologist to find alternatives and/or substitutes, but they felt the clasp was not the right fit for the catheters they used them with.Also made note that some slight irritation occurred where the statlocks were placed, and they were trying to alleviate the soreness.
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Manufacturer Narrative
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The reported event was inconclusive.A potential root cause for this failure could be due to "inappropriate snap fit ".The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog and lot number for this device are unknown.Therefore, bd was unable to determine the associated labeling to review.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.H3 other text : the device was not returned.
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