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

Model Number	27303
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2019
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
It was reported that the device was broken.There were no patient symptoms or complications related to the event.The patient's status was alive-no injury.
Additional Manufacturer Narrative
The returned product did not include the drainage bag.The catheter was connected to the patient line.Cloth was taped around the stopcock and the connection between the catheter and patient line; 19.25 inches of catheter was returned.The device did not meet the requirement for leak and patency test due to the catheter being broken.It is unknown how or when this damage occurred.The instructions for use cautions, ¿low tear strength is a characteristic of most unreinforced silicone elastomer materials.Care must be taken with the handling and placement of the silicone elastomer catheter tubing to avoid cuts, nicks or tears.¿ the device was not tested for tensile testing due to less than 20 inches of catheter being returned.Proteinaceous debris was on the interior of the device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KIT
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8358255
• Report Number: 2021898-2019-00065
• Device Sequence Number: 16194489
• Product Code: GWM
• UDI-Device Identifier: 00673978246048
• UDI-Public: 00673978246048
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K802100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2019

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: 03/31/2022
• Device Model Number: 27303
• Device Catalogue Number: 27303
• Device Lot Number: 213102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 03/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR