MAUDE Adverse Event Report: ST PAUL CADD YELLOW 250 ML MCR WITH FLOW STOP FREE-FLOW PR; SET, ADMINISTRATION, INTRAVASCULAR?

Catalog Number 21-7309-24

Device Problem Particulates (1451)

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

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

One cassette was returned for evaluation.Visual inspection confirmed the reported event.The most probable root cause for contamination is the bags were contaminated during manufacturing of the cassette.A dhr was conducted which indicated all inspections were completed and no issues were noted during manufacture.

Event Description

It was reported that little black particles were found on the inside of the cassette, but outside of the pouch.No patient injury was reported.

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 3012307300-2022-07876 is no longer considered reportable, please disregard any mdr reports associated with it.

• Brand Name: CADD YELLOW 250 ML MCR WITH FLOW STOP FREE-FLOW PR
• 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: 14311908
• MDR Text Key: 290959004
• Report Number: 3012307300-2022-07876
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K031361?
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

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 Catalogue Number: 21-7309-24
• Device Lot Number: 3890931
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/19/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 05/06/2022
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2019
• 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