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

Model Number	G48008
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter occupation: other non-healthcare professional: buyer.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, prior to a hemodialysis catheter insertion the wire guide of a micropuncture transitionless stiffened cannula access set was found uncoiled upon removal from the packaging.Another same type device was used to complete the procedure.There was no noticeable damage to the packaging.The device did not make patient contact.This did not result in prolonged hospitalization or additional procedures.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Event summary: as reported, prior to a hemodialysis catheter insertion the wire guide of a micropuncture transitionless stiffened cannula access set was found uncoiled upon removal from the packaging.Another same type device was used to complete the procedure.There was no noticeable damage to the packaging.The device did not make patient contact.This did not result in prolonged hospitalization or additional procedures.The patient did not experience any adverse effects due to this occurrence.Investigation - evaluation: reviews of the complaint history, device history record, drawing, instructions for use, manufacturing instructions, specifications, and quality control procedures and a visual inspection of the device were conducted during the investigation.The complainant returned one wire guide to cook for investigation.Physical examination of the returned device showed a broken solder at the distal tip, resulting in coil elongation.A document-based investigation evaluation was performed.There have been no other reported complaints for this lot number.One relevant nonconformance was recorded for this product lot.Although there is a non-conformance relevant to the reported failure mode, all non-conforming product was scrapped, and there are 100% inspections to capture this non-conformance.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the drawings, manufacturing instructions, specifications, or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state, ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the available information, cook has concluded that shipping/handling likely contributed to this incident.It is possible that the device solder got caught on the wire guide holder during removal and resulted in coil elongation, but this could not be confirmed.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 11568754
• Report Number: 1820334-2021-01008
• Device Sequence Number: 3459540
• Product Code: DYB
• UDI-Device Identifier: 00827002480087
• UDI-Public: (01)00827002480087(17)230706(10)13285143
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/12/2021

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: 07/06/2023
• Device Model Number: G48008
• Device Catalogue Number: MPIS-501-10.0-SC-NT-U-SST
• Device Lot Number: 13285143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1