MAUDE Adverse Event Report: CAREFUSION MICROBORE EXTENSION SET SET, EXTENSION, INTRAVASCULAR

Model Number 30914

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 04/02/2016

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 the clinician noted air in the 'blue iv filter' of the extension set when she was connecting the new iv tpn line. The clinician attempted to draw out the air bubble with a syringe without success. The rn discovered the extension set 'could not draw at all' which resulted in the uvc being discontinued and a new uvc line inserted.

Manufacturer Narrative

Concomitant medical products: non-bd stand-alone filter; therapy date (b)(6) 2016. The customer¿s report of an air in the line was confirmed. Upon visual inspection, it was noted that the female luer had a hairline crack. There were no scratches on the exterior of the female luer, indicating that no external force had been applied to the female luer. No defects were found on the rest of the set. During functional testing the set began to leak at the female luer crack. Dimensional testing was performed and the non-bd connector was within specification. The root cause of the customer¿s report of a leak was identified as the cracked female luer. The source of the crack is unknown.

Event Description

The rn discovered the extension set ¿could not draw at all¿ which resulted in the uvc being discontinued and a new line was started.

• Brand Name: MICROBORE EXTENSION SET
• Type of Device: SET, EXTENSION, 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: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 5615067
• MDR Text Key: 43887964
• Report Number: 9616066-2016-00584
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 30914
• Device Catalogue Number: 30914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/28/2016 Patient Sequence Number: 1