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As reported, the product was being pulled to use in a procedure.It was noted that a needle was sticking out of the sterile packaging and the personnel who pulled the item was stuck by the needle.They were treated with general first aid care with no adverse events.In regard to the scheduled procedures, no patient care impacted and the procedure was completed successfully with another of the same device.
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Description of event: as reported, the product was being pulled to use in a procedure.It was noted that a needle was sticking out of the sterile packaging and the personnel who pulled the item was stuck by the needle.They were treated with general first aid care with no adverse events.In regard to the scheduled procedures, no patient care impacted and the procedure was completed successfully with another of the same device.Investigation ¿ evaluation: a visual inspection of the images of the device provided by the customer was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, quality control data, and specifications.The complainant did not return the complaint device to cook for investigation.However, images were provided to cook for analysis.An image shows the outer package of the device with a component needle piercing through the back above the attached ifu.This is consistent with the reported failure mode; however, at this time, there is no evidence that a manufacturing deficiency occurred or that the device was manufactured out of specification.A review of complaint history records shows no other complaints associated with the complaint device lot.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied ¿do not use the product id there is doubt the product is sterile.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded that shipping/handling likely contributed to this incident, as there are 100% inspection checks to prevent this failure mode from occurring.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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