MAUDE Adverse Event Report: ST PAUL CADD MEDICATION CASSETTES; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Leak/Splash (1354)

Patient Problems Diarrhea (1811); Headache (1880); Pain (1994); Swelling/ Edema (4577)

Event Date 01/03/2022

Event Type  malfunction  

Event Description

Patient complained of diarrhea daily, first bite jaw pain, headache, complained of pain in right ankle but thinks is related to his (patient's) gout.Took indocin after i arrived, and it eased the pain, has 2+ pitting edema lower extremities (states is decreased from usual).It was reported that "when we changed the cartridge to the one that had been prepared yesterday, we discovered it was leaking.Upon inspection, we discovered fluid in the cartridge between the plastic shell and the bladder.".

Manufacturer Narrative

No product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, smiths medical will reopen this complaint for further investigation.A manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.

• Brand Name: CADD MEDICATION CASSETTES
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14239984
• MDR Text Key: 290386564
• Report Number: 3012307300-2022-07068
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2022

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 Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male