MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY BECKER EDMS II, EURO, GREEN PATIENT LINE; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	27702
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2018
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 tubing under the drip chamber where it meets the y-connection of the injection site did not seem to be glued correctly and came apart.The product was replaced.
Additional Manufacturer Narrative
The returned product was patent and met the requirements for leak testing.It is confirmed that there is a broken connection between the tubing and the y-connection.It is unknown how or when the disconnection occurred.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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: BECKER EDMS II, EURO, GREEN PATIENT LINE
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7632771
• Report Number: 2021898-2018-00303
• Device Sequence Number: 14008614
• Product Code: GWM
• UDI-Device Identifier: 00721902495687
• UDI-Public: 00721902495687
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/05/2018

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: 12/17/2022
• Device Model Number: 27702
• Device Catalogue Number: 27702
• Device Lot Number: 214691677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 07/12/2018; 08/08/2018
• Initial Report FDA Received Date: 06/24/2018
• Supplement Report FDA Received Date: 08/09/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1