MAUDE Adverse Event Report: ROYAL FLUSH PLUS FLUSH CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number G04894

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510(k) number: pre-amendment.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, a hair-like fiber was found within an unopened royal flush plus flush catheter package.This was found within a distribution facility.The device did not reach the end user or make contact with any patient.

Manufacturer Narrative

Correction: d4: this information was incidentally omitted on the initial report.Summary of event: as reported, a hair-like fiber was found within an unopened royal flush plus flush catheter package.This was found within a distribution facility.The device did not reach the end user or make contact with any patient.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control were conducted during the investigation, as well as a visual inspection of the complaint device.The complaint device was returned to cook for investigation.From the investigation of the returned device, a foreign fiber was confirmed within the sealed packaging.A device master record (dmr) review was performed, and device drawings, specifications, and quality control procedures associated with the complaint were identified.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.No related non-conformances were found, and there have been no other reported complaints for this lot number.From the information provided upon review of the dmr, dhr, dhf, ifu, and returned device, cook has confirmed that the device was manufactured out of specification, but that there are no additional nonconforming devices in-house or out in the field.The product ifu instructs the user not to use the product if there is doubt as to whether it is sterile and to inspect the product upon removal from the package.Based on the information provided and the results of the investigation, cook has concluded that a quality control deficiency contributed to the failure mode.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.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 additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ROYAL FLUSH PLUS FLUSH CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10240544
• MDR Text Key: 198329205
• Report Number: 1820334-2020-01262
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002048942
• UDI-Public: (01)00827002048942(17)230409(10)13113283
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

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: No Information
• Device Expiration Date: 01/20/2023
• Device Model Number: G04894
• Device Catalogue Number: HN5.0-38-100-P-10S-PIG
• Device Lot Number: 13113283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1