Visual evaluation of the sample as received confirms the product was correctly sealed at the chevron end where the pouch has been opened.This is indicated by the presence of clean transfer of the seal when the product was opened.At the opening there are no anomalies in the pouch materials or seal found.The remainder of the supplier seal on both sides of pouch remains sealed and is in good condition.The bottom manufacturing seal is also sealed and in good condition.The pouch was then completely opened to show a complete seal transfer to match that of the top chevron seal finding no anomalies in the seal or pouch materials.Based on the product evaluation the received product pouch was correctly sealed prior to being opened.As received the package was opened, as such it cannot be determined why the user felt they could open the package without resistance.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in april, 2018.
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As reported on (b)(6) 2019 the bard modified kugel was pulled from hospital inventory and, "when the circulating nurse attempted to open the sterile package, they could open the package without resistance.They alleged that the package was originally opened.The device was not used." as reported, there was no abnormality reported with the outer product packaging.
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