Investigation summary: samples/ photos: according to the visual analysis of the photos, it was not possible to confirm the complaint.
For this product catalog the date of manufacture and the batch are stamped on the film and the expiration date on the blister is printed on the back of the packaging, ie on the top web containing the following description: "expiration date: 5 years after manufacturing".
Investigation conclusion: not confirmed: bd was unable to confirm this complaint.
Investigation comments: this complaint could not be confirmed as the expiration date is on the back of the packaging, printed on the paper containing the words: "expiration date: 5 years after manufacturing" and the manufacturing date is stamped on the film, as on the photos of the claimed samples.
In addition, this date format for this type of catalog (national angiocath) is contained in internal document (b)(4).
Based on the analysis of the photos, no root cause was assigned to this incident, since the complaint was not confirmed.
Rationale: based on a severity assessment and occurrence it was determined that no capa is required at this time.
The complaint was added to the complaint database for trend analysis, which is regularly monitored.
Dhr review: device history record analysis was not performed since due to the analysis of the photos it was not a manufacturing failure of the manufacturing of the product.
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