MAUDE Adverse Event Report: ST PAUL CADD INFUSION DISPOSABLES PORTFOLIO WITH NRFIT CON; ADMINISTRATIONS SETS WITH NEURAXIAL CONNECTORS

Model Number	21-7605-24
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.One sample was decontaminated inside a plastic bag without its original package.During the visual inspection, the sample received did not present any damage.During the functional testing no problem was found with the assembly of the connector.The complaint was not confirmed.The root cause of the reported issue could not be determined as complaint not being confirmed.No action was taken due to complaint not confirmed.
Event or Problem Description
It was reported that the the disposable cassette tubing became disconnected from the extensions set.No patient injury was reported.

• Brand Name: CADD INFUSION DISPOSABLES PORTFOLIO WITH NRFIT CON
• Common Device Name: ADMINISTRATIONS SETS WITH NEURAXIAL CONNECTORS
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16908907
• Report Number: 3012307300-2023-05525
• Device Sequence Number: 7562387
• Product Code: PWH
• UDI-Device Identifier: 10610586044113
• UDI-Public: 10610586044113
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K162219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2023

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: 21-7605-24
• Device Catalogue Number: 21-7605-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• 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: 11/04/2021
• Initial Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown