MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS ACCESS SET; DYB INTRODUCER, CATHETER

Model Number	G47942
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by a distributor, upon receiving and inspecting a micropuncture transition less access set, it was noted that the sterile packaging was not sealed.Because this was found within a distribution facility, there was no impact to any patient or end user.
Additional Manufacturer Narrative
E1: name and address - (b)(6).G4: pma/510(k) # - k240589 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.
Additional Manufacturer Narrative
Summary of event: as reported by a distributor, upon receiving and inspecting a micropuncture transitionless access set, it was noted that the sterile packaging was not sealed.Because this was found within a distribution facility, there was no impact to any patient or end user.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the returned device was conducted as well.The complaint device was returned to cook for investigation.Physical examination of the returned device found that the bottom seal was not present, and frosting was not noted on the clear film of the pouch.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported relevant complaints for this lot number.Cook investigated all the lots packaged and sealed by the same personnel within the same time as the complaint lot and found no relevant complaints have been reported from the field for the same failure mode.With this information, cook has concluded that this is an isolated incident.The product ifu states, ¿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.¿ a review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned device, suggest that there is evidence that the device was manufactured out of specification.However, there is no evidence of additional non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that the cause of this failure was manufacturing and quality control deficiency.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified, and cook will continue to monitor for similar events.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.

• Brand Name: MICROPUNCTURE TRANSITIONLESS ACCESS SET
• Common Device Name: 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: 21095370
• Report Number: 1820334-2025-00020
• Device Sequence Number: 18299992
• Product Code: DYB
• UDI-Device Identifier: 00827002479425
• UDI-Public: (01)00827002479425(17)270709(10)16145305
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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
• Operator of Device: Health Professional
• Device Model Number: G47942
• Device Catalogue Number: MPIS-401-NT-SST
• Device Lot Number: 16145305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/02/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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