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

Catalog Number UNKNOWN-E

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The product was unavailable for return.Therefore an evaluation of the device performance was not possible.The instructions for use 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.¿ a review of the manufacturing records was not possible as no lot number was provided.All edms devices are 100% leak tested at the time of manufacture.

Event Description

It was reported to medtronic neurosurgery that the becker system was found to be cracking when changing the evd bag.Reportedly, there was no injury to the patient.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM
• Type of Device: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: jeffrey henderson ; 125 cremona drive; goleta, CA 93117 ; 8055718445
• MDR Report Key: 5749392
• MDR Text Key: 48190749
• Report Number: 2021898-2016-00215
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1