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

Model Number 46129

Device Problems Disconnection (1171); Connection Problem (2900)

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

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the tubing which is normally attached bedside where the drainage bag is situated became unattached.The product was replaced and there was no effect to the patient.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information received reported that the drain was first connected on the morning of (b)(6) 2018.It was indicated that there were no accidental pulls on the tubing or any other factors that may have led to the disconnect.

Manufacturer Narrative

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

Manufacturer Narrative

The returned product was patent.The device did not meet the requirements for leak testing due to the patient line tubing-luer connection being disconnected at the ¿y¿ connector.Adhesive was present at the connection.It is unknown how or when the damage 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.

• Brand Name: 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7743785
• MDR Text Key: 116076667
• Report Number: 2021898-2018-00383
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K984053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/31/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2023
• Device Model Number: 46129
• Device Catalogue Number: 46129
• Device Lot Number: 215109538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 09/13/2018; 10/10/2018; 10/29/2018
• Supplement Dates FDA Received: 10/03/2018; 10/04/2018; 10/22/2018; 10/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 18 YR