MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SETS - NON FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7091-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon disconnecting the distal end of the y-port, the remaining connection leaked as it was connected to the patient's cannula.No patient injury was reported.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.Operator of device is unknown.No information provided to date.
Additional Manufacturer Narrative
Other, other text: d5: operator of device: updated.H6: event problem and evaluation codes: updated.H10: device evaluation: two pictures were reviewed.Picture one shows an administration set with a close-up to the y-site connection asv valve, male luer connection and female luer check valve.Picture two shows an administration set with the y-site connection removed.Per the images attached, the complaint is not confirmed.As no product sample was returned, no functional testing could be performed.The reported complaint could not be confirmed.The root cause cannot be determined since the device was not returned for further analysis.The root cause cannot be determined since the device was not returned for the analysis.No corrective action will be implemented as the complaint was not confirmed.No lot or serial number was provided therefore, a device history record (dhr) review could not be performed.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# 617147.

• Brand Name: CADD ADMINISTRATION SETS - NON FLOW STOP
• 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: 15184367
• Report Number: 3012307300-2022-14940
• Device Sequence Number: 20285915
• Product Code: FPA
• UDI-Device Identifier: 10610586024160
• UDI-Public: 10610586024160
• Combination Product (Y/N): N
• PMA/510(K) Number: K000942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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 Model Number: 21-7091-24
• Device Catalogue Number: 21-7091-24
• Was Device Available for Evaluation?: No
• 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: 07/20/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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