MAUDE Adverse Event Report: COOK INC ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET; DYB INTRODUCER, CATHETER

Model Number N/A

Device Problem Contamination (1120)

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

Event Date 02/13/2022

Event Type  malfunction  

Manufacturer Narrative

Customer (person): phone: (b)(6).Occupation: unknown.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

Upon opening the package and before making contact with the patient, foreign matter was noted.The foreign matter was described as "white unidentified objects" on the sheath of the device.Additionally, there was 3-5 cm area on the sheath that was not smooth.The device was not used and another cook rosch-uchida transjugular liver access set, rpn: rups-100 was used to complete the procedure.It was confirmed that storage conditions of the device met requirements.No adverse effects or harm to the patient was reported.

Manufacturer Narrative

Additional information: 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

During preliminary investigation of the returned device, it was discovered that the blue catheter was also damaged with rust-like material.

Manufacturer Narrative

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

The device was returned and visually inspected 01aug2022.In addition to the unknown white substance on the metal stylet, there was also what appeared to be rust present.

Manufacturer Narrative

Investigation ¿ evaluation: sinopharm medical (fujian)trading development co., ltd (china) informed cook on (b)(6)2022 of an issue with a rosch-uchida transjugular liver access set (rpn: rups-100; lot 13987049).The customer stated that, after opening the package, part of the sheath was discovered to have an unknown white matter attached to it.The device did not make patient contact.A replacement set was used to complete the procedure.Review of documentation including the complaint history, device history record (dhr), instructions for use (ifu), and manufacturing instructions, as well as a visual inspection of the device, were conducted during the investigation.One prior to use set was received.An unknown white substance was noted on the metal stylet, and what appears to be rust.On the light blue flexible stiffener near the hub appears to have apparent rust matter on it.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 (dhr).The dhrs for lot 13987049 and all related subassembly lots revealed no recorded non-conformances or additional complaints relevant to the failure mode.Returned rups devices from other previous complaints and inventory at a distribution center were examined for traces of rust.No evidence of rust was found on any of these additional devices.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product ifu, [t_rups_rev4] ¿rosch-uchida transjugular liver access set,¿ provides the following information to the user related to the reported failure mode: ¿how supplied 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 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 a manufacturing deficiency contributed to the event.Upon examination of the returned set, the needle was the affected component.It is possible that traces of the solder and/or flux remained on the device causing corrosion and the observed discoloration.Defect awareness notifications were issued and acknowledged by the responsible personnel.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.

Event Description

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

• Brand Name: ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET
• Type of Device: DYB INTRODUCER, CATHETER
• 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: 13792836
• MDR Text Key: 296077922
• Report Number: 1820334-2022-00406
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10827002069296
• UDI-Public: (01)10827002069296(17)240526(10)13987049
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K171820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• 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: RUPS-100
• Device Lot Number: 13987049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2021
• 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
• Patient Age: 54 YR
• Patient Sex: Male