It was reported that the bard flat mesh sterile package was damaged prior to use.The subject device was discarded by the user facility and was not available for evaluation, as such we are unable to review for root cause determination and no conclusions can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.The instructions-for-use, provided with the device states, ¿this device must be sterile before use.Please inspect the packaging to be sure it is intact and undamaged.¿ should additional information be provided, a supplemental mdr will be submitted.
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As reported, on (b)(6) 2020 prior to an open procedure outside the operating room, the bard flat mesh package was noted to be damaged and there was a concern for sterility breach.There was no patient involvement.The mesh was discarded and a new mesh was used to complete the procedure.
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