MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. INF SET CLEO 31" 9MM; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Patient-Device Incompatibility (2682); Material Integrity Problem (2978)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Caregiver reported that she went to place patients deo and the needle looked a little different than they were used to.When she went to place cleo, patient screamed in pain and there was blood.Caregiver did not have packaging from that set.Author expressed concern that it was not a deo since she said it looked different.Author advised caregiver to not use any products that look different from what they are used to and to contact pharmacy first.No other information available.Reported to (b)(6) by: patient/caregiver.

• Brand Name: INF SET CLEO 31" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 13479735
• MDR Text Key: 285416113
• Report Number: MW5107269
• 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: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2022
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female