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

Catalog Number	46128
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned product was patent.The device did not meet the requirements for leak testing as the drainage bag luer connector was fo und to be broken.The instructions for use (ifu) that accompany the device caution that ¿in order to avoid possible cracking of the luer connectors after cleaning with alcohol, allow to air dry completely prior to connecting the system.¿ the ifu also cautions ¿all connections should be finger tightened.Over tightening can cause cracks and leaks to occur.¿ all edms devices are 100% leak tested at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that there was a rough connection between the drainage bag and the system.According to the report, when returning to the room, the drain was on the floor.Reportedly, the drainage bag fell completely off when the nurse went to empty the bag.
Additional Manufacturer Narrative
Additional information received reported the system was replaced bedside using sterile technique.According to the report, chloraprep was used to clean the connections and there were no accidental pulls on the tubing.Reportedly, there was no harm to the patient.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.
Additional Manufacturer Narrative
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: 6268698
• Report Number: 2021898-2017-00021
• Device Sequence Number: 19201756
• Product Code: GWM
• UDI-Device Identifier: 00673978228754
• UDI-Public: 00673978228754
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K984053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2016

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: 46128
• Device Lot Number: 211866259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Initial Date Received by Manufacturer: 12/21/2016
• Supplement Date Received by Manufacturer: Not provided; 03/07/2017
• Initial Report FDA Received Date: 01/20/2017
• Supplement Report FDA Received Date: 03/23/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR