MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS, INC. HAND PACK ESC/ACS

Model Number	EVHD34
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the event was not returned for evaluation.A follow-up report will be provided upon conclusion of investigation.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.
Event or Problem Description
Foreign debris was found in the fold of the drape which was within acs convenience kit.The debris was discovered while patient was under anesthesia but before incision.The sterile field was deemed contaminated.There was a significant delay while the room was cleaned, and a new sterile field was set up with new supplies and instruments.
Additional Manufacturer Narrative
The device history record for complaint lot number was reviewed.The product lot met all manufacturing requirements prior to release.No rework or special conditions were reported.There are environmental controls in place at the manufacturing site including positive pressure environment, cleaning procedures, non-viable particle monitoring and gowning procedures to minimize opportunity for foreign material occurrence.One complaint photo provided appears to contain some foreign material: however, it's difficult to identify through a photo review.No sample was provided by the complainant.There are some prior complaints received for foreign material over the past 12 months; however, none of these report metal foreign material similar to this occurrence.The site has notified manufacturing personnel of the complaint to monitor for metal particulate presence during assembly.The site will continue to monitor for any additional complaint receipt for this issue.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.

• Brand Name: HAND PACK ESC/ACS
• Common Device Name: HAND PACK ESC/ACS
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS, INC.; 2610 ne industrial drive; suite 220; kansas city MO 64120
• Manufacturer (Section G): LA ADA DE ACUNA, S. DE. R. L. DE C. V.; av. hidalgo no. 6 esq; blvd. luis donaldo colosio; col.educativa, nogales sonora 84093 ; MX 84093
• Manufacturer Contact: nichole coggins ; 2610 ne industrial drive; suite 220; kansas city, MO 64120 ; 8287820529
• MDR Report Key: 20421015
• Report Number: 3003419114-2024-00003
• Device Sequence Number: 12664521
• Product Code: OJH
• UDI-Device Identifier: 00191072209658
• UDI-Public: 00191072209658
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/06/2025

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 Model Number: EVHD34
• Device Catalogue Number: EVHD34
• Device Lot Number: 12-7124011
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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