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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. FIRST PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. FIRST PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Device Problems Material Rupture (1546); Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/29/2016
Event Type  malfunction  
Event Description
Tip of picc line in left arm measured to be at t7.Notified nnp of placement of picc and ordered to pull line back by one cm.Dressing removed using sterile technique and line adjusted per nnp order.Picc line redressed and t tube changed using sterile technique.Attempted to flush picc line with pulsing method.Small amount of resistance met followed by rupture of picc line in between hub and t tube connection site.Notified and ordered to replace picc line at this time.Picc line removed and measured to be at 27 cm total.Notified of ruptured line and line placed in biohazard bag and given to manager.
 
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Brand Name
FIRST PICC
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
one becton drive
franklin lakes NJ 07417
MDR Report Key5875037
MDR Text Key52072201
Report Number5875037
Device Sequence Number1
Product Code FOZ
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 08/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date04/01/2019
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/04/2016
Event Location Hospital
Date Report to Manufacturer08/04/2016
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
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