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

Model Number	G48006
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
As reported, while stocking a micropuncture transitionless stiffened cannula access set, a hair was found inside the packaging.There was no patient involvement.
Additional Manufacturer Narrative
Additional information: d9, h3: it was initially unknown if the complaint device would be returned, but it a device was never returned.Event summary: as reported, while stocking a micropuncture transitionless stiffened cannula access set, a hair was found inside the packaging.There was no patient involvement.Investigation - evaluation: a document-based investigation was performed including a review of complaint history, device history record, manufacturing instructions, quality control data, specifications, and the instructions for use (ifu).The complainant did not return the complaint device to cook for investigation.In response to this incident, cook completed a review of the dhr.The dhr for the reported complaint device lot records no non-conformances.A database search for complaints on the reported lot found no additional lot related complaints from the field.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that non-conforming product exists in house or in field.The instructions for use (ifu) 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.¿ 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.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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 or Problem Description
No new patient or event information since the last report was submitted.

• Brand Name: MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12128028
• Report Number: 1820334-2021-01702
• Device Sequence Number: 19664411
• Product Code: DYB
• UDI-Device Identifier: 00827002480063
• UDI-Public: (01)00827002480063(17)240401(10)13865250
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K171275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Expiration Date: 04/01/2024
• Device Model Number: G48006
• Device Catalogue Number: MPIS-501-10.0-SC-SST
• Device Lot Number: 13865250
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 11/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1