MAUDE Adverse Event Report: COOK INC FLEXOR RADIAL ACCESS SET; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported by materials management, a note was placed with the device that states "was leaking around the sheath." additional information had been requested, no additional information was available at the time of this report.
Additional Manufacturer Narrative
Investigation - evaluation a review of the complaint history, drawings, device history record, instructions for use (ifu), quality control, trends, and visual inspection / functional testing of the returned device was conducted during the investigation.One flexor radial access set sheath with an inserted dilator was returned for the investigation.After flushing the sheath, a leak test was performed.The sheath tubing was occluded with hemostats and a syringe was used to inject water through the connecting tube assembly.Leakage was detected through the center of the silicone disc.The check-flo cap and body were separated to better visualize the silicone disc.There were no apparent signs of tearing.The hole in the center of the disc went completely through and did not seal, thus why the disc did not provide hemostasis.If the disc had not been manufactured to specification, it is probable that the device would have failed leak test inspection.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 that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the available information and the results of the investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.

• Brand Name: FLEXOR RADIAL ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6170079
• Report Number: 1820334-2016-01522
• Device Sequence Number: 730220
• Product Code: DYB
• UDI-Device Identifier: 00827002126602
• UDI-Public: (01)00827002126602(17)190926(10)NS7231556
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2017

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: KCFN-5.0-18-13-RA2.5-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2016
• Supplement Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1