MAUDE Adverse Event Report: COOK INC MIXTER ENDOSCOPIC CHOLANGIOGRAPHY SET; GBZ CATHETER, CHOLANGIOGRAPHY

Model Number	G08045
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer (person): phone: (b)(6).Occupation: (b)(6).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.
Event or Problem Description
It was reported the packaging of a mixter endoscopic cholangiography set had a missing seal "on the underside".This was noticed during initial inspection and prior to patient contact.
Additional Manufacturer Narrative
Investigation ¿ evaluation it was reported to cook that the packaging of a mixter endoscopic cholangiography set, rpn: c-oecs-400-mixter, from lot 13837240, was not sealed.This incident was reported by agility logistics, in brazil, on 24aug2021.The failure was noticed at a distribution center, before the device reached a customer.Reviews of the complaint history, device history record (dhr), quality control, manufacturing instructions (mi), instructions for use (ifu), as well as a visual inspection were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, images of the packaging for the device were provided, showing the end of the package was not sealed.Additionally, a document-based investigation evaluation was performed.A review of the device master record concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record for the reported complaint device lot revealed no relevant non-conformances.A database search did not identify any other events associated with the reported device lot.A review of 3 additional lots correlating to similar devices manufactured on the same day by the same person revealed no other complaints.Consequently, cook concluded the reported failure was an isolated incident.Cook also reviewed product labeling.The product ifu, [c_t_moecs_rev3] ¿mixter endoscopic cholangiography set¿, provides the following information to the user related to the reported failure mode: how supplied: ¿sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.¿ the information provided upon review of the dmr, dhr, ifu, and provided imaging suggest that there is evidence the device was manufactured out of specification.However, there is no evidence suggesting nonconforming product exists either in house or in field.Based on the available information, provided photos, and the results of the investigation, cook has concluded the cause of this event is a manufacturing and quality control deficiency.The appropriate manufacturing personnel were retrained to prevent this from occurring again.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: MIXTER ENDOSCOPIC CHOLANGIOGRAPHY SET
• Common Device Name: GBZ CATHETER, CHOLANGIOGRAPHY
• 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: 12377381
• Report Number: 1820334-2021-02062
• Device Sequence Number: 3528026
• Product Code: GBZ
• UDI-Device Identifier: 00827002080454
• UDI-Public: (01)00827002080454(17)240322(10)13837240
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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 Expiration Date: 03/22/2024
• Device Model Number: G08045
• Device Catalogue Number: C-OECS-400-MIXTER
• Device Lot Number: 13837240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown