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Model Number N/A |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/08/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Lot history record review was completed and confirmed that lot 141112e-cm met release specifications.The acclarent failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).
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Event Description
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Acclarent was informed on 04/15/2016, of an event on (b)(6) 2016, in which the sterile package of an acclarent relieva spin sinuplasty guide, m-110c (lot#: 141112e-cm) was open.The sterility of the package was compromised.There was no report of patient consequence as the guide was not used due to the compromised sterility.
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Manufacturer Narrative
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It was reported that the sterile package of an acclarent relieva® spin sinuplasty guide, m-110c (lot#: 141112e-cm) was open.Acclarent received the package on 5/2/2016.The returned package contained the relieva® spin sinuplasty guide, m-110c.Upon receiving the package, the product was visually inspected and the following were observed: the bottom of the pouch remains sealed.The seal boundary is fairly uniform along the edges.Traces of fiber uniformly left on the plastic film on the opened portion of the pouch.The creases on the left and right of seal surface showed that forces appeared to have been applied in the opposite directions in order to break the seal.This issue was unlikely to have happened during the manufacturing process at acclarent since all devices are manufactured and packaged in accordance with documented specifications procedures and passed all required release criteria.In addition, in line inspections are in place to prevent this type of defect prior to the products leaving the facility.The failure mode of this complaint (pouch was not sealed) cannot be confirmed since acclarent manufacturing processes can be ruled out as a potential cause of the alleged non-conformance.
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Search Alerts/Recalls
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