MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7355-24
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while the customer was infusing total parenteral nutrition (tpn) without lipids using the 0.2-micron filter, despite rigorous priming, removal of bubbles, and following strict directions on the product insert, there were multiple bubbles on the fluid path which form right before the peripherally inserted central catheter (picc) line.The risks of air embolus for the patient was a very big concern.The overnight tpn was infused at approximately 230 ml/hour for 12 hours.The event occurred during infusion.A sample photo was provided.The patient receives home tpn.The reporter noted that the product has been used for nightly home tpn via picc and the customer was told by amerita nextron to continue using it.The patient is the customer's child.The customer was very concerned about the air emboli.A sample photo is provided regarding the product and bubbles that form on the fluid path despite strict adherence to priming.There was patient involvement, and no harm/adverse events reported.
Additional Manufacturer Narrative
H3: device not received by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
No device was returned for investigation.Three photos were attached to the complaint.Per second photo provided, complaint is confirmed per bubbles in the tubing.No sample evaluation could be performed since sample did not return for investigation.There were no customer complaints related to the same lot number and failure mode.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20242168
• Report Number: 3012307300-2024-09410
• Device Sequence Number: 8089826
• Product Code: FPA
• UDI-Device Identifier: 10610586027376
• UDI-Public: (01)10610586027376(17)250729(10)4025376
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K031361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2025
• Device Catalogue Number: 21-7355-24
• Device Lot Number: 4025376
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown