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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7230-24
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/12/2017
Event Type  malfunction  
Manufacturer Narrative
One used cleo® 90 infusion set was received for investigation. A visual inspection of the device confirmed the cannula was detached from the site. A manufacturing verification was performed and produced samples were tested. No detachment was detected in any of the tested samples. A review of the device history record was performed and no anomalies were observed. The most probable root causes were determined to be: the retractor could have had a "tv antenna" condition during the threading of the site and it was not detected during the visual inspection at the manufacturing facility. Visual aids regarding the "tv antenna" condition were not placed in all detection stations in the manufacturing facility. The operator did not segregate appropriate scrap and defective parts were taken as good parts.
 
Manufacturer Narrative
The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.
 
Event Description
It was reported that the cannula of a cleo® 90 infusion set broke off in the patient's skin during a routine change. It was reported the event occurred midway through the procedure. The visiting nurse was able to remove the cannula with tweezers. The nurse was actively monitoring the site for skin irritation. No permanent injury was reported. See mfr: 3012307300-2017-01065.
 
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Brand NameCLEO® 90 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. 4
parque industrial internaciona
tijuana, 22425
MX 22425
Manufacturer Contact
jennifer meng
6000 nathan lane north
minneapolis, MN 55442
7633833078
MDR Report Key6563528
MDR Text Key249783355
Report Number3012307300-2017-01007
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/05/2022
Device Catalogue Number21-7230-24
Device Lot Number77X002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2017
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: 05/12/2017 Patient Sequence Number: 1
Treatment
SUBCUTANEOUS OCTREOTIDE
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