MAUDE Adverse Event Report: COOK INC ROTHBARTH UNI-FLO INFUSION CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
A rothbarth uni-flo infusion catheter was being prepared to be used in an unspecified procedure.It was reported that a crack was observed on the proximal end (hub) of the catheter.The physician was unable to inject the contrast medium.There was no patient involvement.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, quality control, trends, and visual inspection of the returned device was conducted during the investigation.One rothbarth infusion catheter was returned for investigation.Inspection noted a 8mm crack in the hub starting from the proximal end and running parallel to the catheter.A review of the device history record shows there was one non-conformance; however, all nonconforming material is scrapped prior to production of the final lot.There are no indications that the device and final lot was not manufactured to specifications.There were no other reported complaints for this lot number.All angiographic catheters are 100% inspected and verified prior to release.Based on the information provided, examination of the returned product, and the results of our investigation, the root cause has been attributed to shipping/handling of the device.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: ROTHBARTH UNI-FLO INFUSION CATHETER
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6808461
• Report Number: 1820334-2017-02702
• Device Sequence Number: 150317
• Product Code: DQO
• UDI-Device Identifier: 00827002082182
• UDI-Public: (01)00827002082182(17)180904(10)6153172
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2017

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N5.0-35-100-P-16S-0-RIS-16.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/18/2017
• Supplement Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1