Catalog Number UNKNOWN |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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"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 and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.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.(b)(4).
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Event Description
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It was reported that 2 unspecified introsyte introducer broke at the cannula during use.The following was reported by the initial reporter: "it was reported via introsyte introducer survey that the clinician experienced needle breakage.".
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Event Description
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It was reported that 2 unspecified introsyte introducer broke at the cannula during use.The following was reported by the initial reporter: "it was reported via introsyte introducer survey that the clinician experienced needle breakage.".
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Manufacturer Narrative
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H6: investigation summary: bd was unable to perform a thorough investigation as no material number, 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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Manufacturer Narrative
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The following field was updated due to correction: no.Of events summarized: 2.
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Event Description
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It was reported that 2 unspecified introsyte introducer broke at the cannula during use.The following was reported by the initial reporter: "it was reported via introsyte introducer survey that the clinician experienced needle breakage.".
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Search Alerts/Recalls
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