As reported, prior to patient contact, a torcon nb advantage angiographic catheter slid from the package.The bottom of the package was reportedly not sealed.The device did no t make contact with the patient.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Investigation/evaluation: reviews of the complaint history, device history record, instructions for use (ifu), quality control procedure, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one hnb5.0-38-100-p-ns-vert device was returned in its original packaging for investigation; however, the chevron seal was opened.The bottom seal was intact.There was evidence that the package was sealed, but the chevron adhesive transfer on the plastic film was inconsistent and not complete.The dot matrix on the tyvek side had sections in the seal area where it was not completely merged.The side rail seals were completely sealed, and when they were pulled back, there was resistance indicating an adequate seal.The catheter had been removed from the tray and the tray was placed back in the pouch in the incorrect direction.This position was consistent with the customer¿s testimony that the device slid out of the packaging.Additionally, a document based investigation evaluation was performed.There is evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the specifications, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device which states ¿sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile." based on the information provided and the examination of the returned product, investigation has concluded that this event could be traced to a manufacturing supplier deficiency.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.Measures are being conducted to address this failure mode.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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