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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO® 90 9MM X 31" INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CLEO® 90 9MM X 31" INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7231-24
Device Problems Sticking (1597); Device Damaged Prior to Use (2284)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
One cleo® 90 infusion set was returned for investigation. The returned device was received with 3 additional cleo® 90 infusion sets. A review of the device history record, relevant to the reported lot, found no non-conformities or defects during manufacturing. Visual inspection revealed that the adhesive layer was adhered to the white cap of the infusion set. Investigation determined a manufacturing issue was the root cause of the adhesive of the device adhering to the cap.
 
Event Description
It was reported that upon opening the cleo set for use, the membrane was sticking to the inside of the lid rendering it unusable. The customer reported that this occurred in four out of the five units in the pack. The patient's husband stated that there have also been some occasions where the cleo units did not adhere to the skin. The patient's husband also stated that if the medication as is supplied by this product is not actively getting the job done, then the patient's "health deteriorates quite quickly at times and at other times, she deteriorates more slowly. There is no two situations alike. " no further adverse health outcomes were reported. See mfr: 3012307300-2017-00036, 3012307300-2017-00215, 3012307300-2017-00216, 3012307300-2017-00217, 3012307300-2017-00218.
 
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Brand NameCLEO® 90 9MM X 31" INFUSION SET
Type of DeviceSET, 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.
parque industrial internaciona
tijuana, b.c. 22425
MX 22425
Manufacturer Contact
lisa perz
6000 nathan lane north
minneapolis, MN 55442
7633833074
MDR Report Key6247952
MDR Text Key64711090
Report Number3012307300-2017-00214
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 12/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Patient Family Member or Friend
Device Expiration Date02/28/2020
Device Catalogue Number21-7231-24
Device Lot Number75X024
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/12/2017 Patient Sequence Number: 1
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