Catalog Number 381223 |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/16/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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Event Description
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It was reported that bd insyte bl 22ga x 1.0in adapter / connector / hub - not able to connect to mating component the following information was provided by the initial reporter: this complaint came through tga; patient requires re cannulation or multiple cannulations.Stock with batch number batch n#3237898.Removed from circulation.Internal hospital s1 product complaint form submitted.Additional event description: anaesthetist cannulated patient successfully.When needle removed and bung attached the bund was not able to be tightened (multiple bungs tried) the cannula was removed and patient required re canulation.Canula deemed to be faulty.Several patient's same outcome see attached - dir 94964.
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Event Description
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This complaint came through tga; patient requires re cannulation or multiple cannulations.Stock with batch number batch n#3237898.Removed from circulation.Internal hospital s1 product complaint form submitted.Additional event description: anesthetist cannulated patient successfully.When needle removed and bung attached the bund was not able to be tightened (multiple bungs tried) the cannula was removed and patient required re canulation.Canula deemed to be faulty.Several patient's same outcome see attached - (b)(4).
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Manufacturer Narrative
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Based on device history record review, no abnormality was observed during the production of the affected batch.As current control, there is outgoing inspection and hourly in-process inspection in place to check for damaged components.As no photo/sample was received for further investigation, root cause could not be determined.The complaint will be re-opened and re-investigated when photo/sample is received.
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Search Alerts/Recalls
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