Catalog Number 381934 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/09/2020 |
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.(b)(4).
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Event Description
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It was reported that 100 packaged bd insyte" autoguard" shielded iv catheters had longer needles than normal.The following information was provided by the initial reporter, translated from (b)(6) to english, "the outer packing changed, the large package was opened and the minimum package was not opened, the appearance of each product was different, the needle was longer than the previous batch of products.".
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Manufacturer Narrative
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Correction: the investigation found that the photos were comparing different lots of the same product.A review of the bill of material revealed that bd had validated a change in the needle covers which would account for the difference in the length between the two lots.Therefore, this is not mdr reportable.
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Event Description
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It was reported that 100 packaged bd insyte¿ autoguard¿ shielded iv catheters had longer needles than normal.The following information was provided by the initial reporter, translated from chinese to english: "the outer packing changed, the large package was opened and the minimum package was not opened, the appearance of each product was different, the needle was longer than the previous batch of products".
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Search Alerts/Recalls
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