MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	46128
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the patient was connected to the device on (b)(6) 2018, and since then, the tubing was found to be loose and disconnected near the injection site.It was stated the device was removed on (b)(6) 2018 and would be replaced with another one.The patients condition remained the same after the incident.According to the healthcare professionals, there were no environmental/external/patient factors that may have led or contributed to the issue.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The returned product was patent.The device did not meet the requirements for leak testing due to the patient line tubing being disconnected at the ¿y¿ connector.It is unknown how or when the tubing became disconnected.No unusual characteristics were noted.All edms devices are 100% leak tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7719434
• Report Number: 2021898-2018-00368
• Device Sequence Number: 904739
• Product Code: GWM
• UDI-Device Identifier: 00673978228754
• UDI-Public: 00673978228754
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K984053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2018

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: 08/11/2022
• Device Model Number: 46128
• Device Catalogue Number: 46128
• Device Lot Number: 213999476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 10/15/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 10/02/2018; 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR