Five opened devices were returned for evaluation.Upon visual examination, the adhesive layer was found to be adhered to the inserter cap (instead of attached to the inserter/retractor as expected).The most likely causes of the reported issue were determined to be: the adhesive pad became detached; either during adhesive application or after white cap assembly or the adhesive pad was received defective from supplier which then allowed for the adhesive to become detached (after visual inspection).To address the two potential root causes identified, the manufacturing facility modified the assembly procedure to include an additional manufacturing step to ensure bonding between the adhesive pad and the inserter/retractor.The manufacturing facility also modified the 100% inspection of the adhesive pad; procedure was modified to include regular verification of alignment of the equipment.These changes were implemented in november 2015.To address the potential for defective adhesive pad, the manufacturing facility notified the adhesive pad supplier and requested an investigation.Supplier verified no issues were identified during manufacturing of the components listed.No further actions were identified by supplier.
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