MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS ACCESS SET; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
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
It was reported prior to an unspecified procedure, a particle was noted in the sealed package of a micropuncture transitionless access set.Another device was used for the procedure.No adverse effects to a patient as the device did not make contact.
Additional Manufacturer Narrative
Additional information: device available for evaluation.A review of the complaint history, device history record, quality control, and visual inspection of the returned device was conducted during the investigation.A sealed micropuncture transitionless access set was returned.The package was opened for further examination.A thin, dark, plastic-like particle of foreign matter with rough edges was found within the package.The particle is 5mm in length and 1mm wide.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.The root cause was determined to be manufacturing-related.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

• Brand Name: MICROPUNCTURE TRANSITIONLESS ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6798341
• Report Number: 1820334-2017-02612
• Device Sequence Number: 13586117
• Product Code: DYB
• UDI-Device Identifier: 00827002562011
• UDI-Public: (01)00827002562011(17)200410(10)7816383
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2017

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: MPIS-402-NT-U-SST
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1