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

Catalog Number MPIS-501-10.0-SC-SST

Device Problem Contamination (1120)

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

Event Type  malfunction  

Manufacturer Narrative

Reporter occupation: clinical manager.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, when the cath lab opened a micropuncture transitionless stiffened cannula access set, they discovered a hair on the inside of the sterile packaging.No adverse effects have been reported due to this occurrence.Additional patient and event information has been requested.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, when the cath lab opened a micropuncture transitionless stiffened cannula access set, they discovered a hair on the inside of the sterile packaging.No adverse effects have been reported due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.It was initially reported that the device would be returned to cook for investigation but it was never sent back to the manufacturer.A device failure analysis could not be conducted.A device history review could not be performed as no device lot number was provided in this case.A global shipment search on the user facility and complaint device was performed but could not definitively determine the lot number of the complaint device.At this time, cook concluded that no non-conforming product from this lot exists in house or in the field.Cook reviewed the device history file (dhf) for the complaint device.The risk analysis outlines the potential failure modes that could arise from the compromised device packaging.Specifically, the failure mode "packaging does not keep product sterile prior to removal" can be used to assess risk.The document also assesses the severity associated with each failure mode, causes and effects of the failure, current risk controls in place, and the detection level of a particular failure.Current risk controls include multiple 100% qc inspections prior to shipping.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the product labeling.The instructions for use (ifu) provides the following information tot he 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.¿ cook has concluded that the main cause of failure is manufacturing /quality control related.Though there are 100% inspections in place to detect foreign matter, it is still possible for this failure to not be caught.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.Per the quality engineering 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 new patient or event information to report since the previous medwatch report was submitted.

• Brand Name: MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12084378
• MDR Text Key: 260721465
• Report Number: 1820334-2021-01628
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K171275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

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 Catalogue Number: MPIS-501-10.0-SC-SST
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 06/29/2021
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 11/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1