Model Number 442023 |
Device Problem
Device Markings/Labelling Problem (2911)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/04/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that bd bactec¿ plus aerobic/f culture vials (plastic) had the label half peeled off.No patient impact reported.The following information was provided by the initial reporter: this is a report about a labeling issue.According to the customer¿s report, the label is half peeled off.
|
|
Manufacturer Narrative
|
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
|
|
Event Description
|
It was reported that bd bactec¿ plus aerobic/f culture vials (plastic) had the label half peeled off.No patient impact reported.The following information was provided by the initial reporter: this is a report about a labeling issue.According to the customer¿s report, the label is half peeled off.
|
|
Manufacturer Narrative
|
H.6 investigation summary: 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.Product insert warnings and precautions sections states that prior to use, each vial should be examined for evidence of contamination such as cloudiness, bulging or depresses septum, or leakage.Vials showing evidence of contamination should not be used.Also prior to use, the user should examine the vial for evidence of damage or deterioration.Vials displaying turbidity, contamination, or discoloration (darkening) should not be used.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.
|
|
Search Alerts/Recalls
|