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Adverse Event Report

BARD REYNOSA S.A. DE C.V. 9.5FR W/VITACUFF & PERC LONG TERM INTRAVASCULAR CATHETER   back to search results
Model Number 7726952
Device Problems Device breakage; Implant, removal of
Event Date 07/13/2000
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Sub-q break & embolization. The catheter ruptured during chemo treatment. Patient was complaining of pain and burning during the infusion. Catheter broke & embolized, had to be removed, & the embolized piece was successfully snared.

 
Manufacturer Narrative

Findings: a complaint history review for the lot #22cka035 does not reveal any complaints of similar nature for the lot. The complaint that the catheter broke and embolized is confirmed as user related. The appearance of the break site indicates that the catheter was severed due to compression between the clavicle and first rib. The instructions for use accompanying this product inform the user, "catheters placed percutaneously or through a cut-down, into the subclavian vein, should be inserted at the junction and outer middle thirds of the clavicle, lateral to the thoracic outlet. The catheter should not be inserted into the subclavian vein medially, because such placement can lead to compression of the catheter between the first rib and the clavicle, which can cause damage and even severance of the catheter. " during routine complaint file processing bard access system (bas) identified a situation where a small number of mdr reportable complaints had not been filed with fda. This issue stemmed from a processing issue internal to bas. The root cause has been identified and immediate corrective action taken.

 
Search Alerts/Recalls

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Brand Name9.5FR W/VITACUFF & PERC
Type of DeviceLONG TERM INTRAVASCULAR CATHETER
Baseline Brand NameGROSHONG 9.5 FR CATH W/DC W/-2VC
Baseline Generic NameLONG TERM INTRAVASCULAR CATHETERS
Baseline Catalogue Number7726952
Baseline Model Number7726952
Other Baseline ID NumberNONE
Baseline Device FamilyGROSHONG SINGLE, DOUBLE AND TRIPLE LUMEN ACUTE CATHETERS
Baseline Device 510(K) NumberK860256
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Date First Marketed03/28/1986
Manufacturer (Section F)
BARD REYNOSA S.A. DE C.V.
boulevard montebello #1
parque industrial colonial
reynosa, tamaulipas
MEXICO
Manufacturer (Section D)
BARD REYNOSA S.A. DE C.V.
boulevard montebello #1
parque industrial colonial
reynosa, tamaulipas
MEXICO
Manufacturer Contact
bryan ball, mgr
5425 west amelia earhart dr
salt lake city , UT 84116
(801) 595 -0700
Device Event Key336892
MDR Report Key347581
Event Key327349
Report Number1720496-2001-00403
Device Sequence Number1
Product CodeDQO
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 07/13/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/15/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number7726952
Device Catalogue Number7726952
Device LOT Number22CKA035
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/31/2000
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/13/2001
Distributor Facility Aware Date07/13/2000
Device Ageno info
Event Location Hospital
Date Report TO Manufacturer07/13/2000
Date Manufacturer Received07/13/2000
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2000
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on January 30, 2009

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