MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS, INC. CATH LAB PACK

Model Number	SACL75
Medical Device Problem Codes	Product Quality Problem (1506); Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Codes	Abrasion (1689); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No samples were available for return.Medline (the supplier of component) was able to confirm issue based on provided photo.Kit device history record was reviewed, all approvals and inspections were completed.No quality nonconformances were documented.Incident was determined to be a defect in component manufactured by supplier medline.The device history record from supplier was reviewed, product was found to meet specifications, no nonconformances were reported.There were no design changes to component that would have contributed to issue.Root cause was unable to be determined.This was the first incident of this nature reported for this component issue.A quality alert was initiated and teammates were retrained to look for this issue.The supplier medline has indicated they have one similar complaint in history; however, no trend for this issue.
Additional Manufacturer Narrative
The product was not returned for evaluation.American contract systems, inc.Is a convenience kit manufacturer.The complaint component is medline industries (namic division) - (b)(4) (fda registration number: 3015910259), part number 65011247.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
The customer reported an issue with the syringe inside the kit.The edge of syringe penetrated the physician's glove and skin.This incident contaminated the sterile field due to the glove breach.Incident occurred during a cardiac cath procedure.

• Brand Name: CATH LAB PACK
• Common Device Name: CATH LAB PACK
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS, INC.; 85 shaffer park drive; tiffin OH 44883
• Manufacturer (Section G): MEDLINE INDUSTRIES (NAMIC DIVISION) - GLEN FALLS; 10 glen falls technical park drive; glens falls NY 12801
• Manufacturer Contact: nichole coggins ; 85 shaffer park drive; tiffin, OH 44883 ; 8287820529
• MDR Report Key: 21514314
• Report Number: 3008492337-2025-00001
• Device Sequence Number: 9618757
• Product Code: OES
• UDI-Device Identifier: 00191072178404
• UDI-Public: 00191072178404
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): Unknown
• 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): 05/06/2025

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: SACL75
• Device Catalogue Number: SACL75
• Device Lot Number: 70-053242
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 05/06/2025
• 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