Investigation ¿ evaluation: on 19sep2022, a representative of (b)(6) (united states) informed cook that the scalpel in a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray (rpn: c-utlmy-701j-abrm-hc-ihi-fst-a-rd; lot number: 14553056) was rusted.When the kit was opened, they noticed the scalpel had rusted.The kit was discarded, and another kit was obtained to complete the procedure.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedure of the complaint device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 dhrs for the reported complaint device lot 14553056 and the related subassembly lots revealed no related non-conformances.A databases search for complaints on the reported lot found one additional complaint reported from the field reported by the same customer on the same device about a different, unrelated failure.The information provided upon review of device master record and device history record does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Cook also reviewed product labeling.The product ifu, [c_t_ctulmabrm_rev7] ¿cook spectrum central venous catheter minocycline/rifampin antibiotic impregnated power injectable,¿ provides the following information to the user related to the reported failure mode: how supplied: ¿store in a dark, dry, cool place.Upon removal from packaging, inspect the product to ensure no damage has occurred.¿ based on the information provided, no product returned, and the results of the investigation, cook concluded the cause of the failure could not be established.It is possible that the lidocaine broke inside the packaging causing the scalpel to rust and/or the shipping or storage conditions contributed to the rust.However, cook cannot confirm either of these possibilities and there is no indication of manufacturing or design deficiencies.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.
|