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

Model Number	46128
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2019
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
Information was received regarding a patient undergoing csf management surgery.It was reported that the evd small bell was "drained" to the water storage bag, and that the drainage tube was not completely packaged.The issue occurred prior to use, and the device was replaced as a result.There were no related patient symptoms.Additional information received reported that when placing the drainage tube, the integrity of the passage had been confirmed, and there was no pulling condition.When the blood was drained, the main system piston was leaking.
Additional Manufacturer Narrative
The returned product was open upon arrival.The device did not meet the requirements for leak and patency testing due to the reflux valve of the drainage bag not being on the interior of the drainage bag.It is unknown how this occurred.No anomalies were observed upon a review of the dhr.The device did not leak from the main system piston.Therefore the nature of the complaint could not be replicated by laboratory personnel.Proteinaceous debris was observed on the interior of the device.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: 8932696
• Report Number: 2021898-2019-00323
• Device Sequence Number: 16203841
• Product Code: GWM
• UDI-Device Identifier: 00673978228754
• UDI-Public: 00673978228754
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K984053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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: 08/21/2023
• Device Model Number: 46128
• Device Catalogue Number: 46128
• Device Lot Number: 216228602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1