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Product device name: cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set.This device is not cleared for sale in the us, however; cook inc manufacturers a similar device with: product code foz and pma/510(k) #: k081113.Customer (person): phone: (b)(6); postal code : (b)(6).Occupation: supply manager.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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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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Investigation ¿ evaluation: it was reported by a representative of (b)(6) hospital (australia) that the wire guide in a cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set (rpn: c-uqlm-1001j-abrm-hc-rd-au; lot#: 14320570) unraveled.On (b)(6) 2022, the device was inserted into a palliative care patient's femoral vein for central venous catheter placement.After using the dilator, the operator had trouble removing the wire guide, and the wire fractured.It was determined that the separated portion of the device would be retained in the patient to avoid distress to the patient and family.The fragment was retrieved post-mortem on (b)(6) 2022.It was noted that patient death was not related to the spectrum catheter wire guide incident.No other adverse effects were reported for this incident.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.Cook received one used wire guide from the customer.A visual examination found the proximal end of the wire guide stretched and elongated.The wire guide's outer diameter measured within cook specifications.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the device history record for lot 14320570 and records no relevant non-conformances.A search on the sub assembly lots (ic14182104, ic14211852, and ic14211854) found two like non-conformances.One was for flexibility incorrect, and the other was for weld not being caught.There are many procedures to identify these failures, and the nonconformances for both were scraped per cook procedures.A database search for complaints on the reported lot found one additional complaint reported from the field for guide wire fracturing from the same hospital and concluded component failure.There were no other complaints for this lot from other hospitals.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_rev1] ¿cook spectrum central venous catheter minocycline/rifampin antibiotic impregnated power injectable,¿ provides the following information to the user related to the reported failure mode: precautions: ¿do not cut, trim or modify catheter or components prior to placement or intraoperatively.Instructions for use: ¿4.-if straight wire is used, always advance soft, flexible end through needle hub and into vessel.If resistance is encountered during wire guide insertion, do not force wire guide.Withdrawal of wire guide through needle should be avoided; breakage may result.5.While maintaining wire guide position, withdraw needle and safe-t-j wire guide straightener.6.Enlarge puncture site with a number 11 scalpel blade, if required.If dilation is required, dilator can be advanced over wire guide and removed prior to insertion of central venous catheter.How supplied: upon removal from 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 that component failure unrelated to manufacturing or design deficiencies contributed to the event.It is possible that the patient's tortuous or calcified anatomy could have caused difficulty when attempting to place or remove the device, but cook is unable to confirm this.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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