Catalog Number 408380 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/23/2022 |
Event Type
malfunction
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Event Description
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It was reported the the package unit for the bd spinal needle 26ga 3-1/2in was open, thus affecting sterility.There was no report of patient impact.The following information was provided by the initial reporter, translated from portuguese to english: customer would like to report one more incident regarding the material: package is opened, which made impossible to use it.
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Manufacturer Narrative
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Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported the the package unit for the bd spinal needle 26ga 3-1/2in was open, thus affecting sterility.There was no report of patient impact.The following information was provided by the initial reporter, translated from portuguese to english: customer would like to report one more incident regarding the material: package is opened, which made impossible to use it.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 17-nov-2022.H6: investigation summary bd received a 26 gauge spinal needle from lot 1357421 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed that the needle was bent but could not identify any damage to the returned unit's packaging.The returned packaging was found to be intact and sealed even though the needle was bent inside.Therefore, based off the visual inspection the engineer was able to verify the reported defect of bent needle but could not identify any issues with the returned unit's packaging.It was determined that the bent needle was a manufacturing defect caused during the packaging process.
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Search Alerts/Recalls
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