MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS, INC. ACS; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	CDVA23G
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
We just opened 2 sterile packs that were both contaminated due to the outer drape of the pack being damaged.They were both vascular access packs lot#664191 it does not appear that all of the packs with this lot number are damaged but we did open 2 of them that were, the outer wrapper appears fine but the actual drape is compromised that actually ends up covering the table.Therefore the whole system has to be discarded.Possible that the positioning of the plastic supplies in the packs contributed to the holes.Underlying the hole are the plastic pitcher and bowl.

• Brand Name: ACS
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS, INC.; 7802 e telecom pkwy; tampa FL 33637
• MDR Report Key: 9693361
• Report Number: 9693361
• Device Sequence Number: 1742430
• Product Code: OEQ
• UDI-Device Identifier: 00191072073327
• UDI-Public: (01)00191072073327(17)201202(10)664191
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2020
• Report Date (Section F): 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: CDVA23G
• Device Lot Number: 664191
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/24/2020