MAUDE Adverse Event Report: CAREFUSION EXTENSION TUBING SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number EXT TUBING

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

The customer reported that iv fluids and blood leaked from the port needle tubing (before connection to iv tubing).Blood cultures were ordered but the user was unable to draw back on the line.The user reportedly ¿deaccessed pt, reaccessed to draw cultures and deaccessed again as pt was ready for discharge.¿ there was no report of patient harm.

• Brand Name: EXTENSION TUBING SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 7801239
• MDR Text Key: 117735654
• Report Number: 9616066-2018-01349
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2018

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: EXT TUBING
• Device Catalogue Number: EXT TUBING
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 8100,PRI TUBING,8015, THERAPY DATE UNK
• Patient Outcome(s): Required Intervention