Catalog Number UNKNOWN |
Device Problem
Coagulation in Device or Device Ingredient (1096)
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Patient Problems
Thrombus (2101); No Known Impact Or Consequence To Patient (2692); No Known Impact Or Consequence To Patient (2692)
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Event Date 08/26/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Medical device brand name: unknown.Medical device type: unknown.Common device name: unknown.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed in this report.Medical device catalog#: unknown.Medical device lot#: unknown.Medical device expiration date: unknown.Unique identifier (udi) #: unknown.Device manufacture date: unknown.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.
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Event Description
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It was reported that an unknown device had clotting.
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Event Description
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It was reported that a bd vacutainer® device had clotting.
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Manufacturer Narrative
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Event description was changed from an "unknown" device had clotting to a "bd vacutainer®" device had clotting.Medical device brand name was changed from an "unknown" device to "bd vacutainer®".Common device name was changed from "unknown" to "blood specimen collection device".
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Manufacturer Narrative
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Event description was changed from an "bd vacutainer®" device had clotting to an "unspecified bd vacutainer® edta tube" device had clotting.Medical device brand name was changed from a "bd vacutainer®" device to "unspecified bd vacutainer® edta tube".
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Event Description
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It was reported that an unspecified bd vacutainer® edta tube had clotting.
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Search Alerts/Recalls
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