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

Model Number	21-7375-24
Medical Device Problem Codes	Connection Problem (2900); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation in progress.
Event or Problem Description
It was reported that the iv line tubing got disconnected at the filter connection.The product problem occurred during an infusion (iv infusion of ampicillin 2000 mg q4h x 42 days picc 1 lumen).The medication was being delivered via a multi-dose bag intravenously: over 1 hour, every four hours with a tkvo rate of 2 ml/hour continuously.The medication was being delivered under low pressure.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
Pictures were received of the reported issue and it could be seen that in each picture, it was observed that the tubing was loose, however the filter port keep inside tubing, indicating that component filter is broke.A sample was visually inspected and the inlet filter port was found to be loose and it was inside the 72" tube.A review of manufacturing processes was conducted and it was verified that no situations or practices could create the event as described in the complaint description section.The most probable cause was that the filter was damaged after the product left the facility.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9942002
• Report Number: 3012307300-2020-02874
• Device Sequence Number: 19671704
• Product Code: FPA
• UDI-Device Identifier: 10610586027444
• UDI-Public: 10610586027444
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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: No Information
• Device Model Number: 21-7375-24
• Device Catalogue Number: 21-7375-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 05/10/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1