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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPICC PROVENA; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
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BARD ACCESS SYSTEMS, INC. POWERPICC PROVENA; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number S3274335
Device Problem Detachment Of Device Component (1104)
Patient Problem Tissue Damage (2104)
Event Date 01/17/2018
Event Type  malfunction  
Event Description
Called to assess picc line because of a report that it has a tear in the lumen.When i looked at picc line the purple hub and cap was only barely attached to the picc lumen.When i turned the purple cap to assess it, the purple line came off in my hand.The picc line was then removed and nurse updated.
 
Manufacturer Narrative
The following elements have blank data.
 
Event Description
Called to assess picc line because of a report that it has a tear in the lumen.When i looked at picc line the purple hub and cap was only barely attached to the picc lumen.When i turned the purple cap to assess it, the purple line came off in my hand.The picc line was then removed and nurse updated.The dressing that we are using is the institution standard ---the sorbaview shield.The site is cleansed with chg or betadine.The flushing syringe is a 10cc barreled syringe.
 
Event Description
Called to assess picc line because of a report that it has a tear in the lumen.When i looked at picc line the purple hub and cap was only barely attached to the picc lumen.When i turned the purple cap to assess it, the purple line came off in my hand.The picc line was then removed and nurse updated.
 
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Brand Name
POWERPICC PROVENA
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key7316073
MDR Text Key101620005
Report Number7316073
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup,Followup
Report Date 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2018
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberS3274335
Device Catalogue NumberS3274335
Device Lot NumberREBT2073
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2018
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/27/2018
Event Location Hospital
Date Report to Manufacturer02/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age74 YR
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