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

Catalog Number	21-7450-24
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, 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 by the patient that some of the 3ml syringes cartridge from last shipment are sticking and it was very hard or not possible to use them to draw medication.No adverse patient effects were reported by the customer.
Additional Manufacturer Narrative
Other text: no product was returned.The investigation determined the most probable cause to be the 3ml syringes not operating as intended, however this cannot be confirmed as no product was returned for investigation.If the product is returned this complaint will be reopened for further investigation.A history record review was not conducted as product is a finished good and with the supplier.D3, g1, and g2 email is: (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: 17447393
• Report Number: 3012307300-2023-07760
• Device Sequence Number: 15269126
• 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): 01/24/2024

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: Lay User/Patient
• Device Catalogue Number: 21-7450-24
• Device Lot Number: 4266305
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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