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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO SUBQ DISPOSABLES SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CLEO SUBQ DISPOSABLES SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7232-24
Device Problems Loss of or Failure to Bond (1068); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/26/2022
Event Type  malfunction  
Event Description
It was reported that after 2 attempts to insert a soft set that the adhesive for the cannula/hub was not sticking to the patient. Soft set insertion piece inspected on a third unit and noted that the needle was bent. Other soft sets from the same box checked by nurse and several noted to have bent needles. We have also experienced the issue with cannula/hub not releasing from the insertion piece/not sticking to the skin/tegaderm with other units (where there was no issue with bent needles). No patient injury was reported.
 
Manufacturer Narrative
A dhr review was performed subsequent to the manufacturing of the device and prior to its release. No problems or issues were identified during this dhr review. No product or photographic evidence were provided to aid in this investigation. The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications. Lacking any additional evidence, this complaint has been closed as unconfirmed. If the product is returned, smiths medical will reopen this complaint for further investigation.
 
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Brand NameCLEO SUBQ DISPOSABLES
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key14073782
MDR Text Key289106587
Report Number3012307300-2022-06149
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586028410
UDI-Public10610586028410
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 Foreign,User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number21-7232-24
Device Lot Number4213341
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/22/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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