C.R. BARD, INC. (COVINGTON) -1018233 STATLOCK SL FOLEY, UNKNOWN CODE; UNKNOWN FOLEY STATLOCK
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Device Problem
Illegible Information (4050)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/03/2022 |
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 customer was not told to keep the foley statlocks dry nor were the instruction for use (ifu) in the package clear.Stated that the foley statlocks fall off since they discharge from the hospital two days ago, when the statlock get wet from the shower they fall off and they used a piece of masking tape to keep foley from tugging to get to their doctor¿s office to get more statlocks.Inquirer responded that the statlock device might need to be changed more frequently than every seven days if it loses complete contact with the skin.Skin should be clean, dry, and free from any lotions or oils.The pads adhesive comes off quicker the more a person showers.Suggested to cover the statlock with plastic wrap or waterproof dressing during showering or bathing to kept it dry.
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "missing instructions".It was unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "daily maintenance: a.The statlock® device should be assessed daily and changed when clinically indicated, at least every seven days.C.If showering/bathing, cover with plastic wrap or waterproof dressing.D.Conduct skin assessment prior to application and repeat daily per facility protocol." 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 customer was not told to keep the foley statlocks dry nor were the instruction for use (ifu) in the package clear.Stated that the foley statlocks fall off since they discharge from the hospital two days ago, when the statlock get wet from the shower they fall off and they used a piece of masking tape to keep foley from tugging to get to their doctor¿s office to get more statlocks.Inquirer responded that the statlock device might need to be changed more frequently than every seven days if it loses complete contact with the skin.Skin should be clean, dry, and free from any lotions or oils.The pads adhesive comes off quicker the more a person showers.Suggested to cover the statlock with plastic wrap or waterproof dressing during showering or bathing to kept it dry.
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