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

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

Catalog number is unknown.Lot number is unknown.Udi information is unknown.Operator of device is unknown.Premarket (510k) number is unknown.No lot number was provided; therefore, device history record review could not be completed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No additional information or patient outcomes were provided.

Event Description

It was reported the patient states cadd ms3 administration tubing broke off connection to medication syringe and leaked onto skin.The skin has a red itchy rash approximately two inches by two inches.Noted in breast area.Tubing lot numbers not provided.Patient was using medications: remodulin, opsumit, tadalafil.No additional information or patient outcomes were provided.

• Brand Name: CADD
• 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: 15253078
• MDR Text Key: 298197060
• Report Number: 3012307300-2022-05526
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 08/18/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 08/18/2022
• 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 Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 104 KG