MAUDE Adverse Event Report: COOK INC ULTRATHANE INTRO-TIP DESIGN CURVED UNIVERSAL DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problems Unsealed Device Packaging (1444); Component Missing (2306)

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

Event Date 11/18/2022

Event Type  malfunction  

Manufacturer Narrative

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 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

It was reported the packages of two ultrathane intro-tip design curved universal drainage catheters were missing the bottom seal and did not contain the device.As reported, a patient did not experience any adverse effects or require any additional procedures due to this occurrence.

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 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 or that a death or serious injury occurred; nor is it admission 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

In additional information, it was reported that the devices were required for an aorto-femoral bypass procedure.The issue of the seals and devices missing was discovered in the stock room.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation it was reported by (b)(6) hospital (france) that two packages of ultrathane intro-tip design curved universal drainage catheter (rpn: ult6.0-35-25-p-3s-ucd-hc; lot#:14318459) arrived unsealed and were subsequently missing the devices.The issue was discovered on 18nov2022 in a stock room and subsequently, no patient contact was reported.Reviews of documentation including the complaint history, device history record (dhr), manufacturing instructions, quality control procedures, and specifications, as well as a visual inspection of the returned complaint device, were conducted during the investigation.A total of two packages without the catheters were returned to cook for evaluation.The investigation confirmed both packages were missing the end seal.A further visual examination confirmed there was no evidence of frosting on the mylar film at the bottom of the pouches indicating the pouches were not processed with an adequate seal.Additionally, 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 14318459 and the related subassembly lots revealed no related non-conformances.A database search for complaints on the reported lot found no additional lot related complaints from the field.Lots sealed using the same sealing equipment, having the same sealing operator, and having the same packaging qc operator were reviewed from (b)(6) 2020-(b)(6) 2023.A total of 9,315 lots were identified.There have been no other seal related complaints on these lots.All complaints opened since (b)(6) 2020 with sealing of the package missing were reviewed.No link between the lot numbers of these complaints and 14318459 in terms of sealing equipment, sealing operator, or sealing date were identified; therefore, this event is likely isolated.There is no evidence of nonconforming material in house or in the field.The information provided upon review of the returned pouches suggests that the packages were manufactured out of specification.Containment was performed on lot 14318459, but field action was determined not to be necessary.Cook also reviewed product labeling.The product ifu, [t_multi_rev5] multipurpose drainage catheter 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 or 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 a manufacturing/qc deficiency contributed to this incident.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: ULTRATHANE INTRO-TIP DESIGN CURVED UNIVERSAL DRAINAGE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• 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: 15858300
• MDR Text Key: 307698493
• Report Number: 1820334-2022-01770
• Device Sequence Number: 1
• Product Code: GBO
• 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,Followup
• Report Date: 06/01/2023

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: ULT6.0-35-25-P-3S-UCD-HC
• Device Lot Number: 14318459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 02/13/2023; 05/23/2023
• Supplement Dates FDA Received: 02/16/2023; 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2021
• 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