MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SETS WITH AIR-ELIMINATING FILT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7394-24

Device Problem Priming Problem (4040)

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

Event Type  malfunction  

Event Description

It was reported that bag will not prime.No patient injury was reported.

Manufacturer Narrative

Visual inspection was performed of three photos received.During the analysis conducted, it was not possible to identify any obstruction in the assembly.Thus, the failure mode reported is not confirmed.No root cause could be determined since the complaint was not confirmed.No actions taken were performed since the complaint was not confirmed.A device history review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.

Manufacturer Narrative

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 3012307300-2022-08129 is no longer considered reportable, please disregard any mdr reports associated with it.

• Brand Name: CADD ADMINISTRATION SETS WITH AIR-ELIMINATING FILT
• 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: 14332522
• MDR Text Key: 291209696
• Report Number: 3012307300-2022-08129
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027536
• UDI-Public: 10610586027536
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7394-24
• Device Catalogue Number: 21-7394-24
• Device Lot Number: 3984353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• 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