MAUDE Adverse Event Report: ST PAUL CADD EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7108-24
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product sample was received; therefore, visual and functional testing could not be performed.The lot number provided could not be found in our records; therefore, a device history record review could not be completed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It was reported that the line was clogged and was not working.No patient injury was reported.
Additional Manufacturer Narrative
Other, other text: while performing a review of submitted mdr report it was discovered that this file was inadvertently assessed as reportable.No patient death, serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.Report 3012307300-2022-07745 is no longer considered reportable, please disregard any mdr reports associated with it.

• Brand Name: CADD EXTENSION SETS
• 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: 14307131
• Report Number: 3012307300-2022-07745
• Device Sequence Number: 11973428
• Product Code: FPA
• UDI-Device Identifier: 10610586034480
• UDI-Public: 10610586034480
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K974013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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
• Device Model Number: 21-7108-24
• Device Catalogue Number: 21-7108-24
• Device Lot Number: 414648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 06/07/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0148-2022
• Patient Sequence Number: 1
• Patient Sex: Unknown