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

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported that during inspection, the primary packaging was observed to be punctured.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), specifications, trends, quality control, and photo review, was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.Photos were obtained and reviewed.The photos show what appears to be a "v" shape puncture that is less than 1 cm in length in the clear packaging.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events related to this failure mode.There were no other reported complaints for this lot number.Based on the information provided, no product returned, and the results of our investigation; the root cause has been determined to be related to shipping and handling.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: ROYAL FLUSH PLUS FLUSH CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6765950
• MDR Text Key: 81830622
• Report Number: 1820334-2017-02246
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002048942
• UDI-Public: (01)00827002048942(17)190922(10)7268304
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

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 Model Number: N/A
• Device Catalogue Number: HN5.0-38-100-P-10S-PIG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/20/2017
• Initial Date FDA Received: 08/03/2017
• Supplement Dates Manufacturer Received: 11/13/2017
• Supplement Dates FDA Received: 11/21/2017
• Date Device Manufactured: 09/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1