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

Model Number	21-7310-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported the customer stated that during the preparation of the disposable, everything worked well, but as soon as the patient went home, the liquid began to leak.The event occurred during use with a patient.No patient injury reported.
Additional Manufacturer Narrative
Other, other text: h3 and h6 - evaluation codes: updated.Device evaluation: one device was returned for investigation.Visual inspection found no damages, kinks or cuts in the sample received that could cause the failure mode reported.Functional testing confirmed the complaint when a leak was detected.It was identified that the leak point is in the perimeter seal of the medication bag.The most probable root cause of the reported issue was the medication bag became damaged during manufacture and was not correctly segregated.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Production personnel were notified by the quality engineer of the defect reported by the customer; also reinforcement of the correct handling and segregation of the medication bag in the assembly process.

• Brand Name: CADD CASSETTE RESERVOIRS - 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17185147
• Report Number: 3012307300-2023-06538
• Device Sequence Number: 17765974
• Product Code: FPA
• UDI-Device Identifier: 10610586032394
• UDI-Public: 10610586032394
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K081156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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: 21-7310-24
• Device Catalogue Number: 21-7310-24
• Device Lot Number: 4311957
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/14/2023
• 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: 06/05/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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: Unknown