MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS, INC. ACS; STERILE SURGICAL SUPPLY PACK

Model Number	CDHI12D
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Questionable sterility assurance issue; what appeared to be a dead bug was found in the self contained basin/wrap within in the sterile supply pack.Bug was lost during examination process, therefore can not provide for examination.Issue identified & rectified; no patient exposure.Intra-op staff reports the following.While setting up for the case after the patient was already in the operating room, a questionable bug was found in the blue basin in the ortho major pack.The blue basin was wrapped separately from the rest of the pack.After the scrub tech discovered the questionable bug, she did not touch anything else on the sterile field.She also had not removed anything from the wrapped basin.Scrub tech removed gloves and transferred instruments to a separate sterile field.Surgeon notified.A new pack was opened.Quality was informed and pack was saved.

• Brand Name: ACS
• Common Device Name: STERILE SURGICAL SUPPLY PACK
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS, INC.; 4801 west 81st street; bloomington MN 55437
• MDR Report Key: 9086604
• Report Number: 9086604
• Device Sequence Number: 2819886
• Product Code: LRO
• UDI-Device Identifier: 00191072046130
• UDI-Public: (01)00191072046130(17)200603(10)846191
• 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): 08/28/2019
• Report Date (Section F): 08/28/2019

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: CDHI12D
• Device Lot Number: 846191
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2019
• 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: 08/28/2019