MAUDE Adverse Event Report: SMITHS MEDICAL ADS, INC. CADD YELLOW STRIPED ADMINISTRATION SET; CADD YELLOW STRIPED ADMINISTRATION SET 21-7039-24

Model Number 21-7039-24

Device Problems Leak/Splash (1354); Chemical Spillage (2894)

Patient Problem No Information (3190)

Event Date 01/22/2014

Event Type  Injury  

Event Description

Three pts receiving iv chemotherapy reported chemotherapy leaking around the filter of each of these administration sets.Smiths medical part # 21-7039-24.Lot # 43x564.Drug was remixed for each pt and replaced - and remaining tubing sets of the same lot number were returned to the manufacturer.Dates of use: (b)(6) 2014.

• Brand Name: CADD YELLOW STRIPED ADMINISTRATION SET
• Type of Device: CADD YELLOW STRIPED ADMINISTRATION SET 21-7039-24
• Manufacturer (Section D): SMITHS MEDICAL ADS, INC.; dublin OH 43017
• MDR Report Key: 3660790
• MDR Text Key: 4315970
• Report Number: MW5034791
• Device Sequence Number: 2
• Product Code: FPA
• Reporter Country Code: US
• 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: 02/19/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 21-7039-24
• Device Catalogue Number: 21-7039-24
• Device Lot Number: 43X564
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention