MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE PLUS SYS W.PED.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX819T
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It has been reported that the label on the back of an m.Blus plus box (#fx819t) was not labeled with the correct serial number.The serial number matches the other shipped product.The qr code and the label on the product are correct.
Additional Manufacturer Narrative
Correction: d4 (serial number).Investigation: visual inspection: - the label on the back of the outer packaging is not correct; - the serial number of the label is not correct; - qr code, label of sterile packaging and the patient label is correct.Summary of the investigation results: based on our test results, we can confirm that the label on the back of the outer packaging is not correct.The labeling is from the second product which was included in the shipping order.A patient hazard can be excluded, because the label on the sterile product packaging, on the sealing label and on the patient label matches the valve.The examination of the return has been completed with the drafting of this report.A credit note will be generated.Additional actions will be implemented in the form of a capa.

• Brand Name: M.BLUE PLUS SYS W.PED.CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 18425550
• Report Number: 3004721439-2023-00392
• Device Sequence Number: 8015144
• Product Code: JXG
• UDI-Device Identifier: 04041906504823
• UDI-Public: 4041906504823
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• 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
• Operator of Device: Health Professional
• Device Model Number: FX819T
• Device Catalogue Number: FX819T
• Device Lot Number: S15811N138322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown