MAUDE Adverse Event Report: COOK INC PARK BLADE SEPTOSTOMY CATHETER; DXF CATHETER, SEPTOSTOMY

Catalog Number	PBS-300
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/23/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 patient contact, the blade of the park blade septostomy catheter would not open.It is unknown if/how the procedure was completed, but there were no injuries or additional procedures reported.

• Brand Name: PARK BLADE SEPTOSTOMY CATHETER
• Common Device Name: DXF CATHETER, SEPTOSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8173916
• Report Number: 1820334-2018-03841
• Device Sequence Number: 19107177
• Product Code: DXF
• UDI-Device Identifier: 00827002034327
• UDI-Public: (01)00827002034327(17)150801(10)F3647614
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2018

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: 08/01/2015
• Device Catalogue Number: PBS-300
• Device Lot Number: F3647614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1