MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA25 A.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX353T
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A sterile packaging issue was reported.According to the complainant, the internal sterile packaging was not sealed.The scout nurse opened external sterile packaging to hand over onto sterile field for implantation.The valve was placed between two layers of sterilisation steripeel packaging which was not sealed and therefore the valve fell to floor when the surgeon tried to take it from the scout nurse.No patient complications were reported as a result of the incident.The sample will be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: all sterile bags of the complained product were present and showed no deviation.All seal lines of the returned sterile bags are in order.The sterile bag containing the shunt system had a different serial number ((b)(6)) than the two outer packages.Results: based on our investigation results, we could not determine any deviations.The sealing and packaging are in order.When packaging items with a sprung reservoir (e.G.Item fx353t), a perforation protection (consisting of two folded, non-sealed packages) is placed in the first sterile package.Subsequently, the first sealed package is placed into the second sterile package and also sealed.These two sealings can be seen on the returned bags.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.From our point of view, no further regulatory actions are required.

• Brand Name: PROGAV 2.0 WITH SA25 A.SPRUNG 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: 17094113
• Report Number: 3004721439-2023-00163
• Device Sequence Number: 13936138
• Product Code: JXG
• UDI-Device Identifier: 04041906140021
• UDI-Public: 4041906140021
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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: FX353T
• Device Catalogue Number: FX353T
• Device Lot Number: 20055916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• 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