MAUDE Adverse Event Report: COOK INC COOK DOUBLE LUMEN EXTRA FIRM SOFT TIPPED AIRWAY EXCHANGE CATHETER; LRC CHANGER, TUBE, ENDOTRACHEAL

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2022

Event Type  malfunction  

Manufacturer Narrative

Customer (person): postal code: (b)(6), phone: (b)(6).Occupation: unknown.Pma/510(k) #: exempt.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.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.

Event Description

It was reported that hair-like foreign matter was discovered within the sealed packaging of a cook double lumen extra firm soft tipped airway exchange catheter.Another like device was used to complete the procedure successfully.The complaint device did not make patient contact.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: (b)(6) medical center (japan) contacted cook on 12dec2022 concerning a cook double lumen extra firm soft tipped airway exchange catheter set (rpn: c-cae-11.0-100-dlt-ef-st, lot#: 14977225).The customer stated that they found a hair-like fiber in the package on 07dec2022.The procedure was completed with another set.The patient did not experience any adverse effects due to this occurrence.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu) and quality control procedures, as well as a visual inspection of the returned product, were conducted during the investigation.One unused device was returned for evaluation.A hair-like fiber was confirmed to be within the sealed packaging, near the chevron end of the catheter inner pouch.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that process steps were identified to ensure this failure mode does not leave house.A review of the device history record (dhr) for lot 14977225 found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling.This product is supplied with an instructions for use (ifu) pamphlet, c_t_cae_rev6.In the how supplied section it states: upon removal from package, inspect the product to ensure no damage has occurred.Cook confirmed that the product was manufactured out of specification during the device failure analysis.There is no evidence of additional nonconforming product in house or in the field.From the information provided, examination of the returned product and the results of our investigation, a definitive cause for the failure was a quality control deficiency.The product was found to contain foreign matter within the sealed packaging.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.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.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: COOK DOUBLE LUMEN EXTRA FIRM SOFT TIPPED AIRWAY EXCHANGE CATHETER
• Type of Device: LRC CHANGER, TUBE, ENDOTRACHEAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15997412
• MDR Text Key: 307946323
• Report Number: 1820334-2022-01842
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10827002364018
• UDI-Public: (01)10827002364018(17)250927(10)14977225
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-CAE-11.0-100-DLT-EF-ST
• Device Lot Number: 14977225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 04/03/2023
• Supplement Dates FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1