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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) POWERPICC SOLO2 CATHETER 4F MAXIMAL BARRIER TRAY WITH M

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C.R. BARD, INC. (BASD) POWERPICC SOLO2 CATHETER 4F MAXIMAL BARRIER TRAY WITH M Back to Search Results
Catalog Number 9194108D
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Retraction Problem (1536); Failure to Advance (2524)
Patient Problem Embolism (1829)
Event Type  Injury  
Event Description
During picc insertion, picc nurse was inserting picc with sherlock wire into sheath.Sherlock sensor indicated picc was not advancing into svc as expected.Withdrew sherlock wire, wire would not retract.Advanced picc was then able to retract wire.Inserted stiff wire into picc, advanced catheter easily over stiff wire.Examined tip of sherlock wire to re-insert for tip placement confirmation, noted that magnetic tip was missing from sherlock wire.Retracted picc, capped dilator and replaced it into sheath.Flushed picc catheter to determine if magnetic tip fragment was inside, tip not found.Informed md, obtained stat shoulder x-ray revealing tip fragment overlying expected area of axillary vein.Successful retrieval of fragment in the region of the right axillary vein/subclavian vein and placed picc line with fluoroscopic guidance.
 
Manufacturer Narrative
Sample received is not a manufacturers product.Therefore, the device has not been returned to the manufacturer for evaluation a lot history review (lhr) of rexj1297 showed no other similar product complaint(s) from this lot number.
 
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Brand Name
POWERPICC SOLO2 CATHETER 4F MAXIMAL BARRIER TRAY WITH M
Manufacturer (Section D)
C.R. BARD, INC. (BASD)
salt lake city UT
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V.
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX  
Manufacturer Contact
shelly gilbert
605 north 5600 west
salt lake city, UT 84116
8015950700
MDR Report Key3766672
MDR Text Key4486073
Report Number3006260740-2014-00180
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072230
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number9194108D
Device Lot NumberREXJ1297
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received 03/21/2014
Initial Date FDA Received04/11/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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