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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INC. SAF-T WING BLOOD COLLECTION & INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL INC. SAF-T WING BLOOD COLLECTION & INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 982312
Device Problem Difficult or Delayed Activation (2577)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
A report was received stating that following use of the device, the needle could not be fully retracted into the safety mechanism, leaving the needle exposed.There was no patient or clinician injury reported.
 
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.Manufacturer's reference: (b)(4).
 
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Brand Name
SAF-T WING BLOOD COLLECTION & INFUSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL INC.
keene NH
Manufacturer Contact
pete hirte
1265 grey fox rd.
st. paul, MN 55112
6516287384
MDR Report Key3963946
MDR Text Key4561579
Report Number2183502-2014-00328
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K895705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number982312
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/21/2014
Event Location Hospital
Date Manufacturer Received04/21/2014
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 Unknown
Patient Sequence Number1
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