MAUDE Adverse Event Report: BALT USA BARRICADE COIL SYSTEM

Model Number	900039
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference (b)(4).While processing administrative returns of a finished good unit, it was observed that a single with barricade coil final assembly part no: 300000, product 9000390620fl10, lot f220400512 had the incorrect expiration date printed on the pouch label.The date indicated on the unit labeling indicated "2027-04-20", while the actual expiration date should indicate "2027-04-23".The shelf life of the product was shorted by three days from the actual expiration date.Based on the expiration date on the barcode tracking sheet and the date of the sign off for label printing, it can be concluded that the labels were not printed on the date of manufacturing.The labels were printed two days after.However, the nonconforming label has an expiration date of 20apr2027.These labels could not have been printed on 20apr2022 based on the manufacturing date and the date of the sign off for label printing.It is not mentioned within (b)(4) that the date on the computer needs to be verified prior to printing.It is also not clear how the label verification should be performed.(b)(4) points to the finished good drawing, however the finished good drawing does not have specific manufacturing dates.The finished good drawing just states that the expiration date should be 5 years from the date of manufacture, however it does not direct the operator how to compare the expiration date to the manufacturing date.Corrective action for this issue will be handled under balt usa reference capa p-1059.Capa p-1059 is implementing a robust process where labels populated no longer require manual entry and manipulation of the clean rooms laptop system date.Labels will have the appropriate data populated through a single scan of the label tracking slip found within the work order.
Event or Problem Description
It was observed during the return process that a unit from barricade coil final assembly part no: 300000, product 9000390620fl10, lot f220400512 had the incorrect expiration date printed on the pouch label.Is: "2027-04-20" should be: "2027-04-23".

• Brand Name: BARRICADE COIL SYSTEM
• Common Device Name: BARRICADE
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: david vu ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 18506051
• Report Number: 3014162263-2023-00080
• Device Sequence Number: 8044460
• Product Code: HCG
• UDI-Device Identifier: 00818053020407
• UDI-Public: (01)00818053020407(11)220423(17)270423(10)F220400512
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2024

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
• Device Model Number: 900039
• Device Lot Number: F220400512
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown