(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Investigation summary: it was reported packaging foreign matter non-biological / unknown.According to the information received, it was received for analysis an unopened sample of product code 2881, lot pd6708.During the visual inspection of an unopened sample, a detached needle was observed placed in the seal area but not compromising the sterile barrel, since the needle no trough totally the seal area of the overwrap.The manufacturing records were reviewed, and the manufacturing / packaging criteria were met prior to the release of this batch.Per the sample condition the assignable cause of packaging foreign matter non-biological was a needle, suture and/or tab in the seal.
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It was reported that a patient underwent an unknown surgery on (b)(6) 2019 and suture was used.During the procedure, it was found that there had been a foreign substance in the package before use.The product was not used for the patient.There were no adverse patient consequences.Upon evaluation of a returned device, the needle was in the seal of the packaging.
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