MAUDE Adverse Event Report: RYMED RYMED CAPS

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); No Code Available (3191)

Event Date 05/28/2015

Event Type  malfunction  

Event Description

Rymed caps broke.No known pt injuries.Unit: ccu-9.Meds infusing: propofol.Propofol start date: (b)(6) 2015, 1139.Rate in mcg/kg/hr: 50.Rate in ml: 24.7.Refer to reference #'s: mw5055298, mw5055299, mw5055301, mw5055302, mw5055303, mw5055304, mw5055305, mw5055306, mw5055307, mw5055309, mw5055310, mw5055311, mw5055312, mw5055313,mw5055314, mw5055315, mw5055316, mw5055317, mw5055318, mw5055319, mw5055320, mw5055321, mw5055322, mw5055323, mw5055324, mw5055325, mw5055326, mw5055327, mw5055328.

• Brand Name: RYMED CAPS
• Type of Device: RYMED CAPS
• Manufacturer (Section D): RYMED
• MDR Report Key: 4995400
• MDR Text Key: 23136590
• Report Number: MW5055308
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 77