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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD SAF-T-INTIMA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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BECTON, DICKINSON AND COMPANY BD SAF-T-INTIMA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 383323
Device Problem Fail-Safe Design Failure (1222)
Patient Problem No Information (3190)
Event Date 11/21/2017
Event Type  malfunction  
Event Description
Bd saf-t-intima (b)(4).The nurse placed an iv in a patient and went to withdraw needle after placement and the plastic safety cover did not cover the retracted needle.The needle was entirely exposed.Scan number included in equipment detail.Additional information includes: ref (b)(4).Lot 7208558.
 
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Brand Name
BD SAF-T-INTIMA
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
9450 south state street
sandy UT 84070
MDR Report Key7070231
MDR Text Key93333573
Report Number7070231
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903833238
UDI-Public(01)00382903833238
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/23/2017,11/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model Number383323
Device Catalogue Number383323
Device Lot Number7208558
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/23/2017
Device Age1 DY
Event Location Outpatient Diagnostic Facility
Date Report to Manufacturer11/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO OTHER DEVICES
Patient Age59 YR
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