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

Model Number	10373772
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: pcvc-percutaneous central venous catheter.The event reportedly occurred in the nicu; therefore it is presumed the patient was a neonate although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.
Event or Problem Description
It was reported that during infusion tpn/intralipids via pcvc (percutaneous central venous catheter) with the t-connector and iv tubing; the rn observed leaking.The rn stated the leak occurred¿ from the t-connector at the junction between where it screws on and the thin part of the tubing starts¿.Due to a potential compromise in sterility of the central catheter the decision was made by the covering neonatologist to discontinue the pcvc.Upon examination of the t-connector after removal, it was noted to be stiff and less pliable than unused product.
Event or Problem Description
It was reported that during an infusion tpn/intralipids via pcvc (percutaneous central venous catheter) with the t-connector and iv tubing; the rn observed leaking due to a crack.The rn stated the leak occurred¿ from the t-connector at the junction between where it screws on and the thin part of the tubing starts¿.The line was in use for 6/20/19-8/29/19.When the rn attempted to be removed because of the risk of infection from the crack in the extension set, the pcvc catheter broke and the patient had to go to interventional radiology for the removal of the remainder of the line.The infant also required a new line to be placed at a later date.It was later reported upon examination of the t-connector after removal, it was noted to be stiff and less pliable than unused product.The event occurred in nicu.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9178778
• Report Number: 9616066-2019-02786
• Device Sequence Number: 16798066
• Product Code: FPA
• UDI-Device Identifier: 10885403234194
• UDI-Public: 10885403234194
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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
• Operator of Device: Health Professional
• Device Model Number: 10373772
• Device Catalogue Number: 10373772
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8015,8100; PRI TUBING,TD UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention