MAUDE Adverse Event Report: ST PAUL CADD 250 ML MEDICATION CASSETTE RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7308-24

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 02/02/2020

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.A product sample was received for evaluation.Visual and functional testing were performed.There are misalignment in the cassette tube on seven samples.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.A review of the production floor was conducted, a sample of 32 units were taken in order to verify for occlusions, kinked tubing and that the bags were correctly placed; no discrepancies were detected.The most probable root cause is that tube was misaligned during assembly and it was not inspected.Quality alert qa was created in order to assure that the production personnel correctly assemble the cassette tube.Production personnel were retrained by quality engineer.

Event Description

It was reported that upon opening the cassettes, they were found damaged and were unusable.No patient harm was reported.

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 3012307300-2022-07792 is no longer considered reportable, please disregard any mdr reports associated with it.

Event Description

It was reported that upon opening the cassettes, they were found damaged and were unusable.No patient harm was reported.

• Brand Name: CADD 250 ML MEDICATION CASSETTE RESERVOIR
• 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; suite 104; minneapolis, MN 55442
• MDR Report Key: 14309442
• MDR Text Key: 291237495
• Report Number: 3012307300-2022-07792
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586032370
• UDI-Public: 10610586032370
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/03/2022

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: 21-7308-24
• Device Catalogue Number: 21-7308-24
• Device Lot Number: 3859511
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/14/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 05/06/2022
• Supplement Dates Manufacturer Received: 05/20/2022
• Supplement Dates FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0148-2022
• Patient Sequence Number: 1