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

Catalog Number 21-7232-24

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Dyspnea (1816); Low Oxygen Saturation (2477)

Event Date 08/23/2017

Event Type  Injury  

Manufacturer Narrative

Report source: (b)(6).

Event Description

It was reported that "the patient noticed the detachment of the needle 9mm" and "the film iv 3000 keeping the needle in place for infusion" of the cleo® 90 infusion set.The patient was receiving remodulin 5 mg/ml.The patient reported mild dyspnea when the nurse arrived later.The nurse noted the patient's oxygen saturation level was very low at 72% and proceeded to insert another needle and restored remodulin infusion.No other adverse events were reported.

• 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.; avenida calidad no. 4; parque industrial internaciona; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 1265 gray fox road; st. paul, MN 55112 ; 7633833310
• MDR Report Key: 6851131
• MDR Text Key: 85274613
• Report Number: 3012307300-2017-01998
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586028414
• UDI-Public: 30610586028414
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/02/2021
• Device Catalogue Number: 21-7232-24
• Device Lot Number: 76X196
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• 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
• Treatment: ALLOPURINOL; EUTIROX; KANRENOL; KEPPRA; OMEPRAZOLE; OPSUMIT; OXYGEN; RANITIDINE; REVATIO; RIVOTRIL; THEO-DUR
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 85