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

Catalog Number	26040
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was unavailable for return.Therefore an evaluation of the device performance was not possible.All edms devices are 100% leak tested at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that the drainage bag was stuck prior to use.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The drainage bag was returned unattached.It can be connected and disconnected without difficulty.No damage was observed at the connections.Therefore the conditions of this complaint could not be verified by laboratory personnel.The returned product did not meet requirements for patency.The occlusion was observed below the drip chamber and above the drainage line.The device met the requirements for leak testing.A review of the manufacturing records showed no anomalies.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: 6609852
• Report Number: 2021898-2017-00301
• Device Sequence Number: 16353319
• Product Code: GWM
• UDI-Device Identifier: 00673978242323
• UDI-Public: 00673978242323
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2017

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: 07/31/2021
• Device Catalogue Number: 26040
• Device Lot Number: 211883193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: 05/03/2017; 10/20/2017
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 09/07/2017; 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1