MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. LUMBAR EXTERNAL DRAINAGE SYSTEM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Device Problems Break (1069); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2017

Event Type  malfunction  

Event Description

Cna called rn into room, lumbar drain was broken outside the body.Site clamped with sterile gauze, tegaderm and ct clamp.Day before, rn noted drain was kinked.Unkinked the drain.The following day (?)the drain broke - nursing not sure if it was the same spot where the drain was kinked.Doctor stated the tubes get kinked often and can break.Drain removed from patient by doctor.No injury to patient.

• Brand Name: LUMBAR EXTERNAL DRAINAGE SYSTEM
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6379824
• MDR Text Key: 69123425
• Report Number: 6379824
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/15/2017,02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2017
• Event Location: Other
• Date Report to Manufacturer: 02/15/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR