Catalog Number 383552 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/27/2021 |
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: 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.Medical device expiration date: unknown.The customer's address is unknown.(b)(6) 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 nexiva 22 ga x 1.00in sp with maxzero was missing print.This occurred on 16 occasions.The following information was provided by the initial reporter: material no: 383552 batch no: unknown.It was reported that print is missing on the packaging.
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Event Description
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It was reported that nexiva 22 ga x 1.00in sp with maxzero was missing print.This occurred on 16 occasions.The following information was provided by the initial reporter: material no: 383552.Batch no: unknown.It was reported that print is missing on the packaging.
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Manufacturer Narrative
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The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 6/4/2021.D.4.Medical device lot #: 0076354.D.4.Medical device expiration date: 2/28/2023.H.4.Device manufacture date: 3/16/2020.H.6.Investigation: our quality engineer inspected the devices submitted for evaluation.Bd received two sealed packages which were lacking printed product information.The issue was confirmed.Preventative maintenance logs were reviewed, which verified all printing equipment and vision detection systems were up to date and functioning properly.The missing print most likely occurred as a result of human error during the manual inspection process.The dhr for lot 0076354 has been reviewed.No related quality issues or process deviations were found.
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Search Alerts/Recalls
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