MAUDE Adverse Event Report: MEDTRONIC MEXICO BECKER®; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	46129
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an extra ventricular drainage (evd) system post-operatively.It was reported that there was a hole in the tubing during the unclamping of the device for csf drainage process.The changed the evd.There was no reported impact to the patient.There were no environmental/external/patient factors that may have led or contributed to the issue.The issue was discovered during their hourly unclamping of the tubing for csf drainage.When the site states unclamp they mean slide clamp.The holes were located on the drainage bag collection line.
Additional Manufacturer Narrative
Patient information was unavailable from the site.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
H2, h3, h6: the returned edms device had a hole on the main system line tubing connecting to the graduated chamber.Due to the presence of this hole, the device did not pass leakage test.It is unknown how this damage may have occurred.Ifu cautions, "all connections should be finger tightened.Over tightening can cause cracks and leaks to occur".Codes b01, c07, and d02 are applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BECKER®
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13621253
• Report Number: 9612164-2022-00820
• Device Sequence Number: 4725872
• Product Code: GWM
• UDI-Device Identifier: 00763000333683
• UDI-Public: 00763000333683
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K984053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2022

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 Expiration Date: 10/28/2023
• Device Model Number: 46129
• Device Catalogue Number: 46129
• Device Lot Number: 221262144
• 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: 02/06/2022
• Supplement Date Received by Manufacturer: 03/13/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2020
• 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