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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 WITH SURECUFF TISSUE INGROWTH CUFF PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

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BARD ACCESS SYSTEMS GROSHONG 9.5F DUAL-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER Back to Search Results
Model Number N/A
Device Problems Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/19/2017
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, at this time, for evaluation. A lot history review (lhr) of rebq1592 showed one other similar product complaint(s) from this lot number. The complaints for this lot number (rebq1592) have been reported from the same facility. Device not yet returned for evaluation.
 
Event Description
Per medwatch: the red port to the groshong catheter fell off while gently flushing it. The blue port remained intact, the line was being prepared to start a chemo fusion, a repair of the catheter was performed. The catheter port was sequestered.
 
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Brand NameGROSHONG 9.5F DUAL-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF
Type of DevicePERCUTANEOUS, 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
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key6775299
MDR Text Key82709063
Report Number3006260740-2017-01249
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 user facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/05/2017,08/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2022
Device Model NumberN/A
Device Catalogue Number7726950
Device Lot NumberREBQ1592
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/05/2017
Distributor Facility Aware Date05/19/2017
Event Location Hospital
Date Report to Manufacturer07/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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