MAUDE Adverse Event Report: ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7057-24
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that immediately on use, a smiths medical cadd administration set was noted to have a broken drip unit at the plug adapter.The reporter indicated that it was pointed out that the event had a risk of air in the system with catastrophic consequences for the patient if not caught in time.No patient consequences were reported.No adverse effects were reported.
Additional Manufacturer Narrative
Other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problems or issues were identified during this device history review.A sample was received for evaluation.Sample was received in decontaminated conditions without its original packaging.The samples were visually inspected under normal conditions of illumination as per procedure.Only the spike and a part of the star tube were observed; however, we could not detect the mentioned brake at the junction at the spike.During functional testing, leak testing in the received sample could not be carried out as indicated in the procedure due to the broken condition that the sample was delivered.Instead, a syringe was used to introduce water through the spike and a clamp was put in the star tube in order to retain liquid pressure in the tube.A leak was detected at the spike bonding union with star tube thus, the failure mode reported is confirmed.Based on the analysis conducted with the sample received, the failure could not be reproduced.The occurrence for this failure condition could be caused by operator not inserting tubing or components together quick enough, causing solvent to dry before insertion creating the leak.No corrective actions will be implemented.However, this failure condition will continue to be monitored.

• Brand Name: CADD
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12024709
• Report Number: 3012307300-2021-06242
• Device Sequence Number: 17278872
• Product Code: FPA
• UDI-Device Identifier: 10610586020407
• UDI-Public: 10610586020407
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K943310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

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: 01/11/2026
• Device Model Number: 21-7057-24
• Device Catalogue Number: 21-7057-24
• Device Lot Number: 4092487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown