Catalog Number 442023 |
Device Problem
Contamination (1120)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/04/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
B3: date of event is unknown.The date received by manufacturer has been used for this field.D4.Medical device lot #: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Event Description
|
Report 3 of 3.It was reported that while using the bd bactec¿ plus aerobic/f culture vials (plastic) that there was biological contamination.The following information was provided by the initial reporter: we have been potentially experiencing some blood culture bottles contamination.We have been having a few bottles flag positive (from a couple of labs, not just (b)(4)) with yeast in the gram, and then rhodotolura in the culture.This is a highly unusual organism seen in blood cultures (even as a skin contaminant) and we think the contamination is coming from the bottles themselves.
|
|
Manufacturer Narrative
|
H.6.Investigation summary: customer reported a contamination event.Neither photos nor returned good samples were received.Bd was not able to perform an investigation to the retention samples since batch number is unknown.A complaint history review cannot be conducted relating to the incident lot number and the ¿as reported¿ defect code since batch number is unknown.The batch history record could not be reviewed as the lot number is unknown nonetheless batch history records are always reviewed prior to product release.Complaint is unconfirmed.No correctives actions were required.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigation process.H3 other text : see h.10.
|
|
Event Description
|
Report 3 of 3.It was reported that while using the bd bactec¿ plus aerobic/f culture vials (plastic) that there was biological contamination.The following information was provided by the initial reporter: we have been potentially experiencing some blood culture bottles contamination.We have been having a few bottles flag positive (from a couple of labs, not just jhh) with yeast in the gram, and then rhodotolura in the culture.This is a highly unusual organism seen in blood cultures (even as a skin contaminant) and we think the contamination is coming from the bottles themselves.
|
|
Search Alerts/Recalls
|