Catalog Number 393224 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/17/2021 |
Event Type
malfunction
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Event Description
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It was reported that 2 bd venflon¿ pro safety shielded iv catheters experienced a needle that would not disengage.The following information was provided by the initial reporter: patient was acutely unwell and required insertion of a cannula.The cannula was inserted successfully but when the needle was withdrawn to leave the cannula insite, the needle did not retract.The whole unit was removed and she used a different cannula (same product, same lot number) in a different site on the persons body and exactly the same problem occurred.No other harm was caused by this fault, luckily.
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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 2 bd venflon¿ pro safety shielded iv catheters experienced a needle that would not disengage.The following information was provided by the initial reporter: patient was acutely unwell and required insertion of a cannula.The cannula was inserted successfully but when the needle was withdrawn to leave the cannula insite, the needle did not retract.The whole unit was removed and she used a different cannula (same product, same lot number) in a different site on the persons body and exactly the same problem occurred.No other harm was caused by this fault, luckily.
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Manufacturer Narrative
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The following fields were updated due to additional information: d9: device available for eval?: yes.D9: returned to manufacturer on: 12/8/2021.H6: investigation: twelve representative samples were received by our quality team for evaluation.The samples were subjected to visual inspection and separation force testing.No abnormalities were observed, and all samples passed the product specification.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
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Search Alerts/Recalls
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