MAUDE Adverse Event Report: CAREFUSION AALRIS EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number 20029E

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2016

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

The customer reported that the extension set was cracked, leaking, and blood was backing up.No report of patient harm.

Manufacturer Narrative

The customer¿s report of extension tubing cracked and leaked was confirmed.During visual inspection it was noted that the female luer had a vertical hair line crack that measured 10.23mm.The cavity number on female luer is 53.The crack was observed to be on the same side as the gate.The knit line was unable to be detected.There were no other damages or any issues observed with the rest of the set.The female luer was inspected under a microscope, to determine if any stress marks were noted.No stress marks were observed.Functional testing was performed and a leak was observed as fluid flowed through the crack on the female luer.Further visual inspection was performed by supplier quality engineering in which engineering confirmed is an issue with the manufacturing process of the female luer component which is manufactured by a third party supplier.The root cause of the leak was identified as a crack.The cause of the crack was not identified.

• Brand Name: AALRIS 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: 5394739
• MDR Text Key: 36949978
• Report Number: 9616066-2016-00113
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K801614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20029E
• Device Catalogue Number: 20029E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 01/27/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/18/2016; 10/04/2016
• 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 Sequence Number: 1