One (1) poole suction instrument was returned for evaluation of "insufficient heatseal." the packaging lab results showed an opening in the seal area.Proper adhesive transfer was observed in the open seal area, indicating that the seal was initially properly formed.The open seal may have been created by the product pushing through the seal during shipping and handling.This device was manufactured 16-november-2015. a review of the manufacturing documents from the dhr/lhr has verified the devices were produced according to current and approved procedures and material specifications. non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture.Of the lot containing (b)(4) units only this one complaint has been received for this lot product and event description.A 2-year review of device family history revealed 12 complaints involving 15 devices of which 13 were confirmed or are pending evaluation of "insufficient heatseal." (b)(4).To date, there have been no serious injuries or death related to this reported problem.Nonetheless, to prevent future recurrences, an investigation has been opened to address this issue.The reported packaging anomalies were obvious to the distributor, prompting return of the devices for evaluation.Good clinical practice would include examination and verification of the product and its original packaging to ensure both are intact.This package was completely open and would prompt the end-user to discard and obtain a sterile package.As with all medical devices, examination of packaging occurs multiple times prior to use (shipping/receiving, distribution, storage and prior to use).In addition, good clinical practice would include examination and verification of the product and its original packaging to ensure both are intact.If the product and its packaging have been opened/damaged or altered, do not use the product and contact the manufacturer immediately.
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As reported by the distributor in (b)(4), during receiving and inspection of incoming products, 1 package containing a poole suction instrument was discovered to have "insufficient heatseal." there was no patient involvement in this reported problem, as the packaging anomaly was discovered during inspection at the distributor facility prior to distribution to an end-user.This report is being filed based on the potential for injury with recurrence.
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