MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; ENDOSCOPE INTRODUCER KIT

Model Number	SBA56PUIMB
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The caregiver opened the cysto pack for a case and saw a piece of something on the pack.It was seen right away and nothing else was contaminated.There was no harm came to the patient.It looked like a crumb or a small rock.

• Brand Name: CARDINAL HEALTH
• Common Device Name: ENDOSCOPE INTRODUCER KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 8864231
• Report Number: 8864231
• Device Sequence Number: 2390406
• Product Code: NWU
• UDI-Device Identifier: 10888439446616
• UDI-Public: (01)10888439446616(11)190403(17)210201(10)216990
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/19/2019
• Report Date (Section F): 07/19/2019

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: SBA56PUIMB
• Device Catalogue Number: SBA56PUIMB
• Device Lot Number: 216990
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2019
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/19/2019