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

Model Number 21-7302-24

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 12/18/2022

Event Type  malfunction  

Event Description

The patient reported having 2 recall affected cassettes in addition to 13 other not affected cassettes in his possession.The patient reported experiencing jaw pain the day before, which he hasn't experienced in a long time.The patient is unsure if this is related to the recalled cassettes lot.The patient was not experiencing any jaw pain at the time of the report was made and denied ay other symptoms at this time.

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Other text: sample received for investigation prior to used conditions with the original packaging, decontaminated and inside a plastic bag.The sample was visually inspected at a distance of 12" to 16" under normal conditions of illumination to detect sample conditions that could cause functional issues.No damage, kinks or any discrepancies that could cause the failure mode reported.Functional test was performed by filling the sample with 100 ml of water the sample was connected to the pump to look for unusual function.Sample was fully priming and connected without difficult, the pump was set running and no alarms were activated.No issues detected in the sample received, complaint is not confirmed.

Manufacturer Narrative

Other, other text: corrected b1, corrected data: corrected b1 product problem.

• Brand Name: CADD ADMINISTRATION SET WITH FLOW STOP
• 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: 16153133
• MDR Text Key: 308581998
• Report Number: 3012307300-2023-00440
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4329617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 03/09/2023; 06/22/2023
• Supplement Dates FDA Received: 03/10/2023; 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Male