Model Number 383312 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that 11 bd saf-t-intima¿ iv catheter safety systems had excess glue on them.The following information was provided by the initial reporter, translated from (b)(6): "there was excess glue at the front end of the catheter tube in general 2".
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Manufacturer Narrative
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H.6.Investigation: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue was not confirmed upon inspection of the photo since the photo did not show the reported defect.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.A device history record review showed no non-conformances associated with this issue during the production of this batch.
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Event Description
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It was reported that 11 bd saf-t-intima¿ iv catheter safety systems had excess glue on them.The following information was provided by the initial reporter, translated from chinese: "there was excess glue at the front end of the catheter tube in general 2".
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Search Alerts/Recalls
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