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

Model Number	21-7321-24
Medical Device Problem Codes	Device Alarm System (1012); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump exhibited a blockage detected error message.No patient injury was reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Other, other text: a2: age at time of event: updated with additional information received.B5: describe event or problem: updated with additional information received.H6: event problem and evaluation codes: updates are not required.H10: no sample has been received by manufacturing.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., corrected data: g3: correction: report source: mw5112816.
Event or Problem Description
Additional information was received by the manufacturer on 11/1/2022.Patient information was provided.The patient is able to return the devices.
Additional Manufacturer Narrative
H10: device evaluation: twenty retractors and ten subcutaneous infusion sets in used condition inside of the original packaging were returned to manufacturing for investigation.Visual inspection and functional testing were performed.Visual inspection of the returned device at a distance of 12 to 16 inches under normal conditions of illumination revealed no obstructions, damaged, broken, or other defects in any of the joints of the product.The samples were tested for occlusion in the tubing per procedure to look for unusual function.The customer reported issue was not confirmed, no occlusions were detected.The root cause cannot be determined as no fault was found.No corrective actions are required since the complaint was not confirmed.A device history record dhr review was conducted and based upon review of the information provided by the customer, it does not indicate a problem with the initial manufacture of the device.No nonconforming manufacturing records were found.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CADD ADMINISTRATION SETS - 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: 15724751
• Report Number: 3012307300-2022-26706
• Device Sequence Number: 2919921
• Product Code: FPA
• UDI-Device Identifier: 10610586029639
• UDI-Public: 10610586029639
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2023

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: Lay User/Patient
• Device Model Number: 21-7321-24
• Device Catalogue Number: 21-7321-24
• Device Lot Number: 4294065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/02/2022
• Supplement Date Received by Manufacturer: 11/01/2022; 06/14/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 11/08/2022; 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2022
• 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: Female