Catalog Number 394900 |
Device Problems
Leak/Splash (1354); Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/20/2023 |
Event Type
malfunction
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Event Description
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It was reported that the bd connecta¿ plus stopcock cap had a loose connection and caused leakage during priming.The following information was provided by the initial reporter, translated from japanese: "this is a report about a loose cap of the stopcock, resulting in leakage.According to the customer's report, immediately after unpacking, the fitting (connectivity) of the stopcock cap was found to have become looser than usual, which resulted in leakage during priming.
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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 the bd connecta¿ plus stopcock cap had a loose connection and caused leakage during priming.The following information was provided by the initial reporter, translated from japanese: "this is a report about a loose cap of the stopcock, resulting in leakage.According to the customer's report, immediately after unpacking, the fitting (connectivity) of the stopcock cap was found to have become looser than usual, which resulted in leakage during priming.
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Manufacturer Narrative
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H6: investigation summary: our quality engineer inspected the 3 photos, 1 opened sample and 2 unopened samples submitted for evaluation.The reported issues of loose component ¿ leak and leakage were not confirmed upon inspection of the samples.Analysis of the samples showed that they did not have any damages or defects.Bd could not determine a manufacturing related root cause since the defect was not confirmed.There is a possibility that the failure could have occurred due to improper use of the product.It is recommended that prior to the use of bd products to review the instructions for use documentation supplied to ensure the greatest chances of there being no failures during use.Production records were reviewed, and this batch met our manufacturing product specification requirements.
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Search Alerts/Recalls
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