Catalog Number UNKNOWN |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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"unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.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 an unspecified bd syringe was damaged before use.The following was reported by the initial reporter: "it was reported that syringes bend.Verbatim: patient complained the bd flextouch syringes bend.Patient ended the call before any additional information could be obtained.Submitting for review.".
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Manufacturer Narrative
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H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to the batch being unknown, no dhr review can be completed.H3 other text : see h10.
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Event Description
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It was reported that an unspecified bd syringe was damaged before use.The following was reported by the initial reporter: "it was reported that syringes bend.Verbatim: patient complained the bd flextouch syringes bend.Patient ended the call before any additional information could be obtained.Submitting for review.".
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Search Alerts/Recalls
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