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

Model Number 21-7322-24

Device Problem Filling Problem (1233)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2021

Event Type  malfunction  

Event Description

It was reported that lines would not prime.No patient injury was reported.

Manufacturer Narrative

Other, other text: visual inspection and functional testing was performed on one sample returned.No obstructions nor other workmanship defects were detected in none of the joins of the product.No discrepancies were detected the product was prime without difficult, liquid flow through whole devices; thus the failure mode reported is not confirmed.No corrective actions are required since the complaint was not confirmed.A dhr review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

Manufacturer Narrative

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 3012307300-2022-08049 is no longer considered reportable, please disregard any mdr reports associated with it.

• Brand Name: CADD ADMINISTRATION SETS WITH FLOW STOP FREE-FLOW
• Type of Device: 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: 14321231
• MDR Text Key: 291315338
• Report Number: 3012307300-2022-08049
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586029646
• UDI-Public: 10610586029646
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse Practitioner
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7322-24
• Device Catalogue Number: 21-7322-24
• Device Lot Number: 4010271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0148-2022
• Patient Sequence Number: 1