MAUDE Adverse Event Report: ST PAUL CADD MS3 CARTRIDGES; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7450-24
Medical Device Problem Code	Short Fill (1575)
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 disposable was hard to work with by the patient.The patient called saying some of the disposables are fine and other are hard to pull out the syringe.Patient has been throwing them away because of being unable to fill with medication.The fault occurred while in use with the patient.The product issue didn't cause or contribute to patient or clinical injury.The patient was able to successfully continue their infusion.
Additional Manufacturer Narrative
Other, other text: b3: date of event is unknown, no information has been provided to date a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
No product was returned.Unable to confirm reported complaint and determine root cause.If the product is returned this complaint will be reopened for further investigation.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.G1, email address: (b)(4).

• Brand Name: CADD MS3 CARTRIDGES
• 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: 17455508
• Report Number: 3012307300-2023-07799
• Device Sequence Number: 17918748
• Product Code: FRN
• UDI-Device Identifier: 10610586028694
• UDI-Public: 10610586028694
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051568
• 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
• Report Date (Section B): 03/01/2024

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: Other
• Device Catalogue Number: 21-7450-24
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 03/01/2024
• 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: Female