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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS IMPLANTED PERIPHERAL INSERTED CENTERAL CATHETER (PICC); PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

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BARD ACCESS SYSTEMS IMPLANTED PERIPHERAL INSERTED CENTERAL CATHETER (PICC); PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Malposition of Device (2616)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Sample not received.
 
Event Description
Per sales rep, facility reported that the patient had an x-ray to verify picc placement after insertion.The x-ray showed the picc in the chest with correct placement.It was stated that 4 days later the patient had another x-ray for a respiratory condition and it showed the picc was up in the neck.
 
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Brand Name
IMPLANTED PERIPHERAL INSERTED CENTERAL CATHETER (PICC)
Type of Device
PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX  
Manufacturer Contact
teresa johnson
605 n. 5600 w.
salt lake city, UT 84116
8015225435
MDR Report Key6126599
MDR Text Key60846727
Report Number3006260740-2016-00629
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Health Professional
Type of Report Initial
Report Date 11/04/2016
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 NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/23/2016
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 Initial
Patient Sequence Number1
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