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 12/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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.(b)(4).Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.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 while using an unspecified bd tubing set the tubing was damaged.There was no report of patient impact.The following information was provided by the initial reporter: another nurse for the cvicu 3 reported a pin hole directly below the upper fitment which happened a while ago, she did not remember which tubing set it was and it was thrown away.
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Event Description
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It was reported while using an unspecified bd tubing set the tubing was damaged.There was no report of patient impact.The following information was provided by the initial reporter: another nurse for the cvicu 3 reported a pin hole directly below the upper fitment which happened a while ago, she did not remember which tubing set it was and it was thrown away.
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Manufacturer Narrative
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H6: investigation summary.No product or photo was returned by the customer.The customer complaint of component damage - no leak could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the lot number is unknown.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
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Search Alerts/Recalls
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