No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiry date (b)(6) 2020.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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H10: manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation sealed in the inner sterile pouch.Two photos were also provided by the user for review.A visual inspection of both the returned device packaging and provided photos found a hair sealed within the packaging.Therefore, the investigation is confirmed for the reported issue.The definitive root cause for the hair sealed in the packaging could not be determined based on the available information.However, the hair would have been introduced to the packaging at the manufacturing facility during the packaging process.Operator awareness training was completed, covering personal hairnet adjustment and use, assembly table cleaning, and use of the deionizing gun on all products and pack tubes.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date 02/2020).
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