MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS, INC GENERAL SURGERY TRAY

Catalog Number	GBSU13F
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A hair was found in the procedure pack on (b)(6) 2024.The procedure was a neurospine case.The hair was discovered in the or.The incident contaminated the surgical field resulting in reported procedure delay.The complaint site was asked additional impact questions on (b)(6) 2024, (b)(6) 2024.The complaint site has not responded to these inquiries to-date.
Additional Manufacturer Narrative
The product involved in the event was not returned for evaluation.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or has caused serious injury.
Additional Manufacturer Narrative
The product involved in the event was not returned for evaluation.Acs tampa conducted a review of the assembly records associated with the discrepant pack and did not observe any cited events throughout the build.As the issue concerned foreign matter, acs operations also reviewed its current environmental/gowning procedure to ensure the production team is continuing to exercise proper gowning techniques and raising awareness if foreign matter is found during production.Due to the limited details provided in the complaint, acs cannot determine the origin/root cause of the hair presence in the pack.Manufacturing was completed in accordance with stated procedures.Housekeeping records reflect proper environmental controls to include compliance with the standard gowning procedure.A root cause was not determined.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or has caused serious injury.H3 other text: device not returned.

• Brand Name: GENERAL SURGERY TRAY
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS, INC; 7802 e telecom pkwy; tampa FL 33637
• Manufacturer (Section G): AMERICAN CONTRACT SYSTEMS, INC.; 7802 east telecom pkwy; tampa FL 33637
• Manufacturer Contact: nichole early ; 7802 e telecom pkwy; tampa, FL 33637 ; 8287820529
• MDR Report Key: 19387904
• Report Number: 3003309947-2024-00001
• Device Sequence Number: 19851474
• Product Code: LRO
• UDI-Device Identifier: 00191072210838
• UDI-Public: 00191072210838
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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 Catalogue Number: GBSU13F
• Device Lot Number: 929241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown