MAUDE Adverse Event Report: COOK INC DILATOR SET; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Catalog Number	C-JCDS-100-CHB
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
It was reported that prior to the procedure, it was noted that the pediatric dilator tip was cracked.It was further noted a large crack in the dilator tip.Another kit was used to complete the procedure.There were no adverse consequences reported due to this event.

• Brand Name: DILATOR SET
• Common Device Name: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8167927
• Report Number: 1820334-2018-03776
• Device Sequence Number: 2640465
• Product Code: DRE
• UDI-Device Identifier: 00827002103979
• UDI-Public: (01)00827002103979(17)190422(10)6896386
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2018

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 Expiration Date: 04/22/2019
• Device Catalogue Number: C-JCDS-100-CHB
• Device Lot Number: 6896386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1