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

Catalog Number 21-7230-24

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)

Patient Problems Hyperglycemia (1905); Discomfort (2330); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that a cleo® 90 infusion set was in use with a patient when an uncontrolled spike in blood glucose was observed in less than 24 hours of use.Once observed, after 4 hours of no response to repeated insulin boluses, the site was removed.It was reported that the site was removed due to the high blood glucose at approximately 28 hours after initial placement.Upon site removal, it was observed that the infusion set tubing remained in the patient's body under her skin and lodged into the patient's tissue.It was suspected that the site breakage occurred prior to removal.It was noted that the site was placed and adhered normally after the area was thoroughly cleaned, skin tac applied, and allowed to dry.The patient was unable to remove the tubing on her own and experienced discomfort.The tubing remains in the patient's body and an appointment with an endocrinologist was made to consider an outpatient surgical removal.The event is considered ongoing.No permanent injury was reported.See mfr: 3012307300-2017-00190.

Manufacturer Narrative

Please note: the reporter returned a device for investigation.The device was not properly labelled prior to shipment and therefore was not properly identified at receiving.

Event Description

It was further reported that while at the emergency room, the patient received multiple numbing injections prior to the health professional's attempt to remove the infusion set cannula.The patient placed the cleo® 90 infusion set around their midsection (belly/abdomen and upper side area).According to the report, the cannula remains inside the patient and the patient's body was not dislodging the cannula.It was reported that the patient was advised that they will need to see a general or plastic surgeon to have the cannula removed.No information was provided regarding the potential date of the surgery.

• 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 MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6249002
• MDR Text Key: 64736975
• Report Number: 3012307300-2017-00191
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 21-7230-24
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2017
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR
• Patient Weight: 66