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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 9.5F DUAL-LUMEN CV CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS GROSHONG 9.5F DUAL-LUMEN CV CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Fluid Leak (1250); Device Dislodged or Dislocated (2923)
Patient Problem No Code Available (3191)
Event Date 04/17/2017
Event Type  malfunction  
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 for evaluation. A lot history review (lhr) of reay0111 showed one other similar product complaint(s) from this lot number. The complaints for this lot number (reay0111) have been reported from the same patient.
 
Event Description
The patient reported that on (b)(6) 2017 she had a groshong cvc that became dislodged within 2 weeks of placement and the tpn she was receiving leaked out. Patient states she was hospitalized to replace device as well as receive iv antibiotics to prevent infection.
 
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Brand NameGROSHONG 9.5F DUAL-LUMEN CV CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key6974788
MDR Text Key90850773
Report Number3006260740-2017-01889
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K860256
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 10/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number6626954
Device Lot NumberREAY0111
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Home
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 Treatment Data
Date Received: 10/24/2017 Patient Sequence Number: 1
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