MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO® 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Bent (1059)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Information was received indicating that the catheter was bent to a smiths medical cleo® 90 infusion set.The patient reported a blood sugar higher than 340 requiring additional insulin to bring it to a therapeutic level.The patient recovered with no further adverse effects.

Manufacturer Narrative

Four cleo® 90 infusion sets were returned for analysis in used conditions.Visual inspection revealed that the retractor was active and the base was missing.Relevant document were reviewed and deemed adequate.A review of manufacturing process was performed.Line clearance record, inserter assembly operation, training records, maintenance records of site threader were all reviewed; no discrepancies noted.Three samples from the production line was inspected and given the worse test cases.No detachment was detected.Based on the evidence no root cause was determined as the complaint was not confirmed.

• Brand Name: CLEO® 90 INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MANUFACTURING; s.a. de c.v.; a d no.4 parque industrial int; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7067105
• MDR Text Key: 93204570
• Report Number: 3012307300-2017-02500
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 11/29/2017
• Supplement Dates Manufacturer Received: 05/10/2018
• Supplement Dates FDA Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention