Catalog Number 367856 |
Device Problem
Device Handling Problem (3265)
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Patient Problem
Chemical Exposure (2570)
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Event Date 07/06/2018 |
Event Type
Injury
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Manufacturer Narrative
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Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.Tech services sent the sds to the customer.Follow-up phone call with customer found that poison control gave instructions and patient is doing well.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Root cause description: as there was no sample or photo available for evaluation, a root cause could not be determined.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that the patient drank the additive in bd vacutainer® k2 edta (k2e) 5.4mg blood collection tubes.Furthermore bd informed the customer to call poison control as the additive is not designed for consumption.It was reported that the physician called the poison control, evaluated the patient's symptoms, and instructions was given to the patient's mother by the physician, the patient was sent home.
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Manufacturer Narrative
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Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: required intervention.Device single use?: no.Device returned to manufacture: no.
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Event Description
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It was reported that the patient drank the additive in bd vacutainer® k2 edta (k2e) 5.4mg blood collection tubes.Furthermore bd informed the customer to call poison control as the additive is not designed for consumption.It was reported that the physician called the poison control, evaluated the patient's symptoms, and instructions was given to the patient's mother by the physician, the patient was sent home.
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Search Alerts/Recalls
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