Catalog Number UNKNOWN |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/27/2021 |
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 catheters were not working and the spacing was too small to hold the tube and the patient experienced pain.Per customer follow up via phone on (b)(6) 2021, the complainant reported that the statlock was not staying closed while using it with 16 fr silicone catheter.Customer had to use tape to keep it closed and also stated that one of the statlock was not sticking to the leg.
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Event Description
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It was reported that the catheters were not working and the spacing was too small to hold the tube.The patient experienced the pain.Per customer follow up via phone on 27jan2021 the complainant reported that the statlock was not staying closed while using it with 16 french silicone catheter.The customer had to use the tape to keep it closed.Also stated that one of the statlock was not sticking to the leg.
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Manufacturer Narrative
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The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to the adhesive chemistry not appropriate for application (poor quick stick characteristics).It was unknown whether the device had met relevant specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The product catalog number and the lot number for this device was unknown.Therefore bd was unable to determine the associated labeling to review.H11: section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.
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Search Alerts/Recalls
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