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Model Number UNKNOWN |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Exposure to Body Fluids (1745)
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Event Date 01/10/2019 |
Event Type
Injury
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Manufacturer Narrative
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A sample was requested but not provided; however, the statement provided on twitter was accompanied by a photo of the user experience.A device history record is not available as the device code and the lot code was not provided.All information reasonably known as of 27jan2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by o&m halyard, inc.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 o&m halyard, inc.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).Device not returned.
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Event Description
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It was reported via social media that a physician experienced an adverse event.After follow-up by an o&m halyard representative, the physician stated, "one dr.Stated that he had a injury on his hand and was bothered that it was covered in blood after the procedure." additional information was requested but not provided.
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Manufacturer Narrative
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The actual complaint product was not returned for evaluation; however, a picture was attached to the record and the failure mode could be identified as channeling.Channeling is a condition in which blood/liquids are transferred from the outer surface of the sleeve that flow into the surgical gloves through small creases that are created between the sleeve fabric and glove that allow the blood/liquids to reach the cuff of the gown.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 10mar2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by o&m halyard, inc.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 o&m halyard, inc.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.
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Search Alerts/Recalls
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