C.R. BARD, INC. (COVINGTON) -1018233 SL FOLEY SWIVEL SILICONE TRICOT 25BX; STATLOCK DEVICE
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Model Number FOL0102 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/13/2021 |
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 wanted to know why only one little swab was there when there used to be two swabs in the tray.The customer also stated that they were having issues with the statlock not sticking.It was also stated that this was an ongoing issue for at the least the last 6 months.The customer also mentioned that they received product through the veterans administration.Per customer contact via phone on 13aug2021, it was stated that, now, statlocks are only coming with one skin prep pack and also the statlocks were not sticking well.It was stated that sometimes, the statlock did not stick on a full day.This had been ongoing for about six months.It was also stated that skin prep wipes were sometimes dried out.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.
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Event Description
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It was reported that the customer wanted to know why only one little swab was there when there used to be two swabs in the tray.The customer also stated that they were having issues with the statlock not sticking.It was also stated that this was an ongoing issue for at the least the last 6 months.The customer also mentioned that they received product through the veterans administration.Per customer contact via phone on 13aug2021, it was stated that, now, statlocks are only coming with one skin prep pack and also the statlocks were not sticking well.It was stated that sometimes, the statlock did not stick on a full day.This had been ongoing for about six months.It was also stated that skin prep wipes were sometimes dried out.
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Search Alerts/Recalls
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