MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0517CSF10
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed during the return process that a unit from optima coil final assembly product opti0517csf10, lot f230100270 had the incorrect expiration date printed on the carton label, however the pouch label was correct.
Additional Manufacturer Narrative
Balt usa reference (b)(4): on (b)(6) 2024, a quality control technician was processing return units under sr#: (b)(6) from balt brazil per sop0041.Sr#: (b)(6) consisted of six units of lot # f230100270.Of the six units, only one unit's carton label was affected by the discrepancy.After reviewing the manufacturing records, it was identified that one label was destroyed when applying labels to the carton on (b)(6) 2023 for this manufacturing lot.The label was reprinted and accounted for on the label reconciliation form, however, no retain label was kept as part of the reprint.The operator who performed the reprint did not refer to wi-004 to update the product shelf-life date and left the date as (b)(6) 2023.The expiration date was calculated to be five years after the manufacturing date, hence the expiration on the carton being (b)(6) 2028.The confirmation that only one label was destroyed confirms that only one discrepant label was printed and applied to the units.Corrective action for this issue will be handled under balt usa reference capa p-1059 and capa-p-1061.Capa p-1059 has implemented 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.Capa-p-1061 is in the process of implementing a barcode scanning verification for label information on both pouches and cartons.This verification ensures that critical details such as gtin, lot number, expiration date, and manufacturing date are accurate and consistent.

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine 92618
• Manufacturer Contact: david vu ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 19274336
• Report Number: 3014162263-2024-00028
• Device Sequence Number: 15190786
• Product Code: HCG
• UDI-Device Identifier: 00818053026157
• UDI-Public: (01)00818053026157(11)230117(17)280117(10)F230100270
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172390
• 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): 05/08/2024

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: OPTI0517CSF10
• Device Lot Number: F230100270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• 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