MAUDE Adverse Event Report: CAREFUSION SYRINGE TUBING SET; SET, ADMIN, INTRAVASCULAR.

Model Number SYR TUBE

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Vomiting (2144)

Event Date 01/02/2020

Event Type  Injury  

Manufacturer Narrative

No product returned.Because no product was returned or expected to be returned, no failure investigation could be performed.The root cause of the customer's experience was not identified additional information including patient's demographics requested, but was not provided.

Event Description

It was reported that during a midazolam infusion, the iv tubing set cracked at the hub and leaked.The baby required prn dose of midazolam and had emesis due to agitation.

Event Description

It was reported that during a midazolam infusion, the iv tubing set cracked at the hub and leaked.The baby required prn dose of midazolam and had emesis due to agitation.

Event Description

It was reported that during a midazolam infusion, the iv tubing set cracked at the hub and leaked.The baby required prn dose of midazolam and had emesis due to agitation.

• Brand Name: SYRINGE TUBING SET
• Type of Device: SET, ADMIN, INTRAVASCULAR.
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9847497
• MDR Text Key: 183890447
• Report Number: 9616066-2020-00902
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2020

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
• Device Operator: Health Professional
• Device Model Number: SYR TUBE
• Device Catalogue Number: SYR TUBE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/01/2020; 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,8110,SYRINGE,THERAPY DATE (B)(6) 2020; THERAPY DATE (B)(6)2020
• Patient Outcome(s): Other