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

Catalog Number	46128
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned product was patent and met the requirements for leak testing.There was proteinaceous debris noted within the drainage bag.A review of the manufacturing records showed no anomalies.All external drainage and monitoring systems are 100% leak tested at the time of manufacture.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.
Event or Problem Description
It was reported to medtronic neurosurgery that there was an issue connecting a transducer to the luer lock port of the system.According to the report, when the customer attached the transducer to the drain, it cracked the luer lock connection.It was stated this caused a leak in the system and the system kept leaking.Reportedly, it appeared the transducer seemed to only screw in 2 threads into the drain with one thread loose.
Additional Manufacturer Narrative
Additional information received reported the drain was removed on (b)(6) 2017.The patient had since been discharged and there was no injury to the patient.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: 6596212
• Report Number: 2021898-2017-00286
• Device Sequence Number: 746393
• Product Code: GWM
• UDI-Device Identifier: 00673978228754
• UDI-Public: 00673978228754
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K984053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2017

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: 08/31/2021
• Device Catalogue Number: 46128
• Device Lot Number: 211965228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2017
• Supplement Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 06/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1