BECTON, DICKINSON & CO. (SPARKS) BD RAPID DETECTION OF SARS-COV-2 VERITOR¿; CORONAVIRUS ANTIGEN DETECTION SYSTEM
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Catalog Number 256089 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Eye Injury (1845)
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Event Date 09/27/2021 |
Event Type
Injury
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Manufacturer Narrative
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Eua # (b)(4).Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that while testing with bd rapid detection of sars-cov-2 veritor¿ the cap was loose on tube and when mixing reagent the sample went into the operators eye.Operator sought medical attention and blood tests were performed.Eua # (b)(4).The following information was provided by the initial reporter: operator, was using face shield but had flicked it up as shield had fogged up.As he was processing the test, he placed the dropper lid on top of the reagent tube but cap didn't clip into place (was loose).As he flicked the reagent tube to mix, reagent flicked out and went into the operators eye.Medical practitioner was contacted, ordered saline flush and once complete operator went to medical care for full books, as per any body intrusion injury.
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Manufacturer Narrative
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H.6.Investigation: this statement is to summarize the investigation results regarding the complaint that alleges operator processed test with loose reagent¿s tube cap while face shield flicked up when using kit rapid detection of sars-cov-2 veritor ce (material # 256089), batch number unknown.Bd quality performs a systematic approach to investigate operator processed test with loose reagent¿s tube cap while face shield flicked up complaints.This approach involves review of manufacturing batch history records, visual inspection of retention samples, and visual inspection of customer returned samples, if applicable.An investigation could not be performed as no batch number was provided.Operator was using face shield but had to flicked it up as the shield had fogged up, while he was processing the test.The operator placed the dropper lid on top of the reagent's tube but the cap didn't clipped into place (was loose).As he flicked the reagent tube to mix, the reagent flicked out and went into the operator's eye.Medical practitioner was contacted, and ordered saline flush and once completed the operator went to medical care for full books, as per anybody intrusion injury.The injury would have been avoided if the face shield was not flicked up during testing and also follow bd's ifu 500050809_ifu_256089_multilingual_en_ca, page 3, the use of personal protective equipment.The complaint was unable to be confirmed.There are no current trends against operator processed test with loose reagent¿s tube cap while face shield flicked up issues.Bd quality will continue to closely monitor for trends.There were no corrective actions taken at this time.
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Event Description
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It was reported that while testing with bd rapid detection of sars-cov-2 veritor¿ the cap was loose on tube and when mixing reagent the sample went into the operators eye.Operator sought medical attention and blood tests were performed.Eua # (b)(4) the following information was provided by the initial reporter: operator, was using face shield but had flicked it up as shield had fogged up.As he was processing the test, he placed the dropper lid on top of the reagent tube but cap didn't clip into place (was loose).As he flicked the reagent tube to mix, reagent flicked out and went into the operators eye.Medical practitioner was contacted, ordered saline flush and once complete operator went to medical care for full books, as per any body intrusion injury.
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