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

Catalog Number	21-7115-24
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.B3: unknown.
Event or Problem Description
It was reported that the disposable detached.Patient involvement is unknown.
Additional Manufacturer Narrative
Other, other text: g1,2 email is: regulatory.Responses@icumed.Com.Additional information was received.The issue occurred during infusion and while in use with the patient.Per the reporter, there were no patient adverse effects; no medical treatment was needed.The event was resolved and new tubing was used to provide medication to the patient.
Additional Manufacturer Narrative
One sample was received for evaluation.Visual inspection revealed the sample was received in a plastic bag, not in its original packaging and in decontaminated conditions.Functional testing was not performed since the sample device returned was broken.The reported complaint was confirmed.The root cause was determined to be caused by the union asv valve with the y-site was stressed when attempted to be open which caused the valve to be broken.Device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.For all enquiries or follow-up questions related to the record, do not use (b)(4)located in sections g.1., please direct those to the following: (b)(4).

• Brand Name: CADD EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 18016319
• Report Number: 3012307300-2023-09946
• Device Sequence Number: 7582056
• Product Code: FPA
• UDI-Device Identifier: 10610586034503
• UDI-Public: 10610586034503
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K000942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2024

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 Catalogue Number: 21-7115-24
• Device Lot Number: 4342671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/08/2023; 03/04/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 11/30/2023; 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown