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Adverse Event Report

BD OPHTHALMIC SYSTEMS (RYCROFT) .30X22.0 MM (30GX7/8") BD VISITEC ANTERIOR CHAMBER CANNULA   back to search results
Catalog Number 585738
Event Type  Malfunction   Patient Outcome  Required Intervention;
Event Description

The complaint items were included in ophthalmic procedure kit 589713. Company has received a report covering 3 incidents. It was reported by the customer that when hydrating the wound at end, the plastic hub of the cannula shattered, leaving a third of the hub attached to the cannula and the other two thirds to the luer lok syringe. The connect on between the two was checked thoroughly, and primed before insertion into the eye. The same happened in all 3 incidents. In one incident, this caused a major problem with the procedure causing a vitreous hemorrhage.

 
Manufacturer Narrative

Complaint sample has been obtained and will be evaluated. One of the complaint samples has been obtained and is being evaluated. The complaint has been reported on a custom kit component, an anterior chamber cannula of a custom ophthalmic procedure kit kitted specifically for hospital. This same cannula is also sold as a sterile finished good. The kit component, the rycroft cannula may be used in over 45 custom kit configurations. The reported events seem to be isolated to only hospital. No other complaints have been received from any of the other custom kits or the cannula sold as a sterile finshed good on the two lots reported or any other lots manufactured. Product evaluation of the returned broken cannula is ongoing and a inservice sales followup with hospital has been conducted. No other events have been reported these events have occurred.

 
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Brand Name(RYCROFT) .30X22.0 MM (30GX7/8")
Type of DeviceBD VISITEC ANTERIOR CHAMBER CANNULA
Baseline Brand Name(RYCROFT) .30X22.0 MM (30GX7/8")
Baseline Generic NameBD VISITOR ATERIOR CHAMBER CANULA
Baseline Catalogue Number585738
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BD OPHTHALMIC SYSTEMS
411 waverley oaks rd.,
bldg. 2, suite 229
waltham MA 02452 8405
Manufacturer (Section D)
BD OPHTHALMIC SYSTEMS
411 waverley oaks rd.,
bldg. 2, suite 229
waltham MA 02452 8405
Manufacturer Contact
pat filosa
411 waverley oaks road
bldg. 2, suite 229
waltham , MA 02452
Device Event Key467497
MDR Report Key478688
Event Key453711
Report Number1211998-2003-00002
Device Sequence Number1
Product CodeHMX
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Invalid Data
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number585738
Device LOT Number4200023
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/01/2003
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/01/2002
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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