MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD - EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7106-24

Device Problem Fluid/Blood Leak (1250)

Patient Problem Underdose (2542)

Event Date 05/29/2019

Event Type  Injury  

Event Description

Per spontaneous call from the pt's husband, they informed us that there was a leak in the pt's line and that she was not getting any medication for a period of time and pt was beginning to notice affects of not receiving the medication.Pt was advised to go to the hosp via paramedics and was advised to place a peripheral line.No further info available at this time.Unk what effects pt was experiencing or if pt went to hosp.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD - EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 8679173
• MDR Text Key: 147497084
• Report Number: MW5087193
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 21-7106-24
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR