MAUDE Adverse Event Report: ST PAUL CADD CASSETE RESERVOIR 100 ML; SET, ADMINISTRATION, INTRAVASCULAR

Model Number CASSETTE RESERVOIR.

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 10/17/2019

Event Type  malfunction  

Event Description

Information received a smith medical cadd reservoir cassette contains a photo and described as a feather inside the cassette but appears to look like a spring coiled.The cartridge is 100 milliliters where leaking is reported in the inner cassette.No patient adverse events reported.

Manufacturer Narrative

Other, other text: one sample was returned for analysis.No discrepancies were detected with the product and neither was a leakage found during leak testing.The following are relevant documents which were reviewed and deemed adequate and correct with respect to testing and inspection activities: pm-1026 rev.109 procedure for operation, inspection and packaging of cassette bag.Qp bag-tj rev.103 cassette bag assembly and packaging.Pm-1009 rev.109 cassette bag loading.Pm-1011 rev.118 cassette leak testing, install ffp clip and luer capping.Qp 67-2265 rev.116 deltec cassette (international and enteral).A review of the manufacturing process for a review of the manufacturing process for p/n 21-7300-24 l/n 4019421, was conducted by quality engineer on(b)(6)2020 , in order to verify that there are no situations or practices that could create the event as described in ?complaint description? section.Note: p/n 21-7300-24 is manufactured with the same manufacturing procedures, process controls and inspections as p/n 21-7302-24.However, p/n 21-7300-24 has housing in color yellow.The following operations were reviewed, in order to verify that the operations were properly performed, also to ensure that the operations complied with gmp?s requirements and shm procedures: the bag loading operation in the cassette line was reviewed; no discrepancies were found.Production line was reviewed; no discrepancies were found.An inspection to the work stations was conducted, in order to verify for sharp edges and sharp objects in the magnus production line and the cassette production line; no sharp objects were found the leak test was audited during ten (10) cycles, in order to verify that the leak test was properly performed; for each cycle five (5) units are tested.The leak test was performed according to the test method stated in the manufacturing procedure; no leakages were detected during the fifty (50) units tested.In magnus line, production performs a 6 psi bubble test for the detection of leakage, to a sample of ten (10) ay bags every two hours.In cassette line, production performs a 100% in-process leak test is performed during the manufacturing of the cassette assembly.In magnus line, quality takes one (1) bag in order to perform a 6 psi bubble test for the detection of leakage, at the start up, the beginning of lot and after a break of 30 min.In magnus and cassette lines, quality verifies that the leak tests are properly performed.The customer reported: leak in the pouch of the medication cassette".No root cause has to be determined since the complaint was not confirmed due the fact the sample was tested, and no discrepancies were found.

• Brand Name: CADD CASSETE RESERVOIR 100 ML
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 9350790
• MDR Text Key: 167367505
• Report Number: 3012307300-2019-06126
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/20/2024
• Device Model Number: CASSETTE RESERVOIR.
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 3757277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1