Catalog Number UNKNOWN |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/12/2021 |
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.Unknown manufacturer: (b)(4).Medical device expiration date: unknown.The customer's address is unknown.(b)(6) usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that unspecified bd¿ pmcf-q-syte-vial-access spike broke during use.This occurred on 10 occasions.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via survey response that the clinician experienced vial access spike breaks during use (10).
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Manufacturer Narrative
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H6: investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.
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Event Description
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It was reported that unspecified bd¿ pmcf-q-syte-vial-access spike broke during use.This occurred on 10 occasions.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via survey response that the clinician experienced vial access spike breaks during use (10).
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Search Alerts/Recalls
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