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

Model Number	21-7091-24
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No information provided to date.No product or photographic evidence was provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history review (dhr) was not conducted, based upon review of the information provided by the customer, as it does not indicate a problem with the initial manufacture or prior repair of the device.
Event or Problem Description
It was reported that during use the device began leaking on the floor and blood was backing up in the proximal port.The connection between the tubing and runner line was cracked.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: CADD ADMINISTRATION SETS - NON 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; 14th floor, north tower; minneapolis, MN 55442
• MDR Report Key: 15164109
• Report Number: 3012307300-2022-14658
• Device Sequence Number: 12195569
• Product Code: FPA
• UDI-Device Identifier: 10610586024160
• UDI-Public: 10610586024160
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K000942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

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: Other
• Device Model Number: 21-7091-24
• Device Catalogue Number: 21-7091-24
• Device Lot Number: 4271203
• 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: 07/28/2022
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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