Catalog Number 442023 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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G5.Pma/510k info: k113558, k222591.H.3.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 that before using bd bactec¿ plus aerobic/f culture vials (plastic) there was a hole found and the media was leaking.The following information was provided by the initial reporter: when did the event occur? -- before use.According to the customer's report, there was a hole at the top of the bottles and the media was leaking.
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Manufacturer Narrative
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It has been determined that the mdr mfr # 3008352382-2023-00113 has been submitted in error.The event occurred before use and therefore there was no report of serious injury, medical intervention, or reportable device malfunction.
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Event Description
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It was reported that before using bd bactec¿ plus aerobic/f culture vials (plastic) there was a hole found and the media was leaking.The following information was provided by the initial reporter: when did the event occur? before use according to the customer's report, there was a hole at the top of the bottles and the media was leaking.
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Search Alerts/Recalls
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