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Blank fields on this form indicate the information is unknown or unavailable.E1: (b)(6).E3: occupation = quality assistant.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.
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Event summary: as reported, dirt was found in the packaging of a guardia¿ access embryo transfer catheter.The device did not make patient contact and was found during the process of receiving and checking products.Investigation ¿ evaluation: a document-based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control (qc) procedures, as well as a visual inspection and functional test were conducted on the device.Two guardia¿ access embryo transfer catheters were returned in an unopened package.Foreign matter was observed on the inner pouch of the guide catheter in roughly the same location on both products.A document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed one recorded non-conformance relevant to the failure mode where 6 devices were scrapped.A database search did not identify any other complaints associated with the reported device lot.Review of the device history record, complaint history, quality control documents, and device failure analysis indicates that the device was not manufactured within specifications but does not suggest items in the lot or similar devices in the field or in house are nonconforming.The product ifu "embryo transfer catheter," t_k-j-etc2_rev1 includes the following related to the failure mode: note: one cell mea tested and passed with 80% or greater blastocyst development within 96 hrs.Usp endotoxin (lal) tested and passed with 20 eu or less per device.How supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened and undamaged.Do not use the product if there is doubt as to whether the product is sterile store in a dark, dry, cool place avoid extended exposure to light.Upon removal from the package, inspect the product to ensure no damage has occurred.Based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded a manufacturing deficiency contributed to the reported failure.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment 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.
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