MAUDE Adverse Event Report: ST PAUL CLEO 90 SUBCUTANEOUS; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Product Quality Problem (1506); Patient-Device Incompatibility (2682)

Patient Problems Urticaria (2278); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Type  malfunction  

Manufacturer Narrative

D4 is unknown; no further information provided to date.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported the patient had concerns that a 'bad box of injectors' led to frequent injection site changes; the patient had, at least, weekly subcutaneous site changes due to itchiness, localized swelling, and several circumferential non-palpable purpura in several stages of healing throughout the abdomen.The patient also reported he would continue using the infusion sets for his administration while monitoring for any changes.

Manufacturer Narrative

B3: date of event unknown; d4: catalog number, lot number, expiration date and udi number is unknown; g5: 510k is unknown; h4: device manufacture date is unknown, no information has been provided to date.No serial/lot number was provided; therefore, a device history record (dhr) review could not be conducted.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.

• Brand Name: CLEO 90 SUBCUTANEOUS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17168122
• MDR Text Key: 317550658
• Report Number: 3012307300-2023-06426
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

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: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Male