C.R. BARD, INC. (COVINGTON) -1018233 CHANNEL DRAIN, 15FR. ROUND HUBLESS FULL FLUTED WITH 4.7MM TROCAR; WOUND DRAIN
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Catalog Number 072229 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/20/2023 |
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.
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Event Description
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It was reported that customer wanted to ask if the bard 15fr drains with the trocars were new or if there was a change in product in the last few months.Customer struggled with getting the trocars to glide through the skin when inserting them.(lot#nghn2729 and lot#nghq2397).Per follow up via email on 25jul2023, customer stated that the trocar tip was nice and sharp.Issue occurred when pulling trocar through skin.It was extremely difficult the more it was fed through the skin, making the physician tug on the device with force.This could also result in a sharp stick.It was not safe to use.They also stated no patient harm.
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Event Description
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It was reported that customer wanted to ask if the bard 15fr drains with the trocars were new or if there was a change in product in the last few months.Customer struggled with getting the trocars to glide through the skin when inserting them.(lot#nghn2729 and lot#nghq2397).Per follow up via email on 25jul2023, customer stated that the trocar tip was nice and sharp.Issue occurred when pulling trocar through skin.It was extremely difficult the more it was fed through the skin, making the physician tug on the device with force.This could also result in a sharp stick.It was not safe to use.They also stated no patient harm.
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Manufacturer Narrative
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The reported event was unconfirmed because the reported failure could not be reproduced.Visual evaluation of the returned sample noted 13 unopened (with original packaging), channel drain.Visual inspection of the sample noted the surface of the torcar was smooth and uniformed on the returned samples.This does meet specification which states that "drains must be smooth and not contain embedded bubbles or built-up material".No root cause could be found because the reported event was unconfirmed.A dhr is not required since the reported failure was unconfirmed.The reported event is unconfirmed a labeling review is not required.Correction: e 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 actual/suspected device was inspected.
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