MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEM MAJOR CATH LAB PACK; GENERAL SURGERY TRAY

Model Number	HGMA13
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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
The customer alleged the sterile labels are disintegrating.This incident occurred while treating a patient.The coloring on the medication labels was rubbing off.The labels are included in custom procedure pack and utilized to label syringes and medications.The flaking of the label was getting all over the sterile field and instruments as well as the physician's hands.Additional information was requested on three separate occasions on december 18, 2024, december 19, 2024, and december 30, 2024, with no response.
Additional Manufacturer Narrative
The complaint lot device history record was reviewed.No issues were found, all product was found to meet inspection acceptance criteria prior to final release.The root cause is suspected to be associated with printing labels in larger quantities where ink did not dry properly.Qa techs spend a minimum of two hours each shift on the production floor ensuring inspections are taking place and inspecting product with teammates to ensure compliance.A quality alert was issued for complaint awareness.The production team will now only print colored labels in increments of ten to allow ink to properly bond to labels.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: MAJOR CATH LAB PACK
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEM; 1601 se gateway drive; suite 120; grimes IA 50111
• Manufacturer (Section G): AMERICAN CONTRACT SYSTEM; 1601 se gateway drive; suite 120; grimes IA 50111
• Manufacturer Contact: nichole coggins ; 1601 se gateway drive; suite 120; grimes, IA 50111 ; 8287820529
• MDR Report Key: 21101005
• Report Number: 3007069947-2024-00003
• Device Sequence Number: 8934820
• Product Code: LRO
• UDI-Device Identifier: 00191072004932
• UDI-Public: 00191072004932
• Combination Product (Y/N): N
• 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): 01/29/2025

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: HGMA13
• Device Catalogue Number: HGMA13
• Device Lot Number: UNKNOWN
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 01/29/2025
• 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