|
E1: customer name and address = (b)(6).Postal code: (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
|
|
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary as reported, the seal to a guardia¿ access embryo transfer catheter packaging is not completely sealed.Half of the inner catheter is stuck in the sealing of the package.Another device of the same type was used to complete the procedure.No adverse effects were reported.Investigation ¿ evaluation a document based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), and manufacturing instructions (mi), as well as a visual inspection of the device were conducted.One device was returned with the outer packaging.The transfer catheter inner pouch seal had been compromised on the proximal end.There was a portion of a guide catheter that was caught in the seal and cut.A review of the device history record found one similar nonconformance for 4 devices recorded for the lot.The non-conforming devices were scrapped prior to lot release.Due to the individual nature of packaging the product, one non conformance in the field does not indicate additional non conformances in the additional non conformances in the field.Additionally, there have been no other complaints filed for this lot.Therefore, there is no evidence to suggest that nonconforming product are in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state, " caution: sterile if the package is unopened or undamaged.Do not use if the package is broken.¿ based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded the cause of the complaint is manufacturing related.The employees who packaged the product (and still work at cook) were made aware of the defect.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
|
