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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4F SL POWERPICC 3CG MB; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

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BARD ACCESS SYSTEMS 4F SL POWERPICC 3CG MB; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER Back to Search Results
Model Number CK000537
Device Problem Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reay0638 showed one other similar product complaint(s) from this lot number.
 
Event Description
Facility reported single lumen picc was placed on 6/6/17, with 3cg "patient not in a-fib, length added in effort to ensure picc remained at placement".Picc malpositioned on (b)(6) 2017, and was removed.A tunneled cvc was placed in interventional radiology.
 
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Brand Name
4F SL POWERPICC 3CG MB
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 Key6750174
MDR Text Key81514994
Report Number3006260740-2017-01166
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741105173
UDI-Public(01)00801741105173
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2017
Device Model NumberCK000537
Device Catalogue NumberCK000537
Device Lot NumberREAY0638
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2017
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received 07/11/2017
Initial Date FDA Received07/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2016
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 Age62 YR
Patient Weight120
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