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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
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/25/2017
Event Type  Injury  
Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation. Report stated the patient was a child; however, the exact age was not provided.
 
Event Description
It was reported that during removal of the cleo® 90 infusion set, the soft tube remained in the patient's abdomen and "disseminated" from the infusion set. The infusion set had been in patient use for 72 hours and had been used for a continuous infusion of terbutaline. An attempt was made to remove the soft tube from the patient at "north tecs a+e"; however, it could not be removed. The patient was given a course of oral antibiotics. No permanent patient injury reported.
 
Event Description
It was further reported that prior to the reported event, the patient had caught the infusion site in school. While the patient was at "a&e", it was observed that the soft set was palpable in the patient's abdomen and the set was also confirmed by x-ray. The soft cannula was unable to be removed from the patient and the patient was started on flucloxacillin 250mg four times per day. According to the report, the patient continued to use the cleo® 90 infusion set to administer terbutaline with no further issues. The patient did not experience issues with the cannula that remained in the abdomen.
 
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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, b.c 22425
MX 22425
Manufacturer Contact
lisa perz
6000 nathan lane north
minneapolis, MN 55442
7633833074
MDR Report Key6523373
MDR Text Key73754546
Report Number3012307300-2017-00899
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2017
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 Treatment Data
Date Received: 04/26/2017 Patient Sequence Number: 1
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