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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS3 WHITE BLEND; STOP COCK
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS3 WHITE BLEND; STOP COCK Back to Search Results
Catalog Number 394900
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/17/2019
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the connecta plus3 white blend experienced a loose connector or separation of connector and injector during use.The following information was provided by the initial reporter: when connecting with the infusion see, it didn't fit properly.
 
Manufacturer Narrative
Investigation: a device history review was conducted for lot number 8338871.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, the samples submitted were evaluated by our quality engineers, and was subjected to leakage testing.Testing results were unable to identify any abnormalities in the device that could have lead to leakage.Unfortunately based on these results , the root cause for this complaint could not be determined at the conclusion of our review.
 
Event Description
It was reported that the connecta plus3 white blend experienced a loose connector or separation of connector and injector during use.The following information was provided by the initial reporter: when connecting with the infusion see, it didn't fit properly.
 
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Brand Name
CONNECTA PLUS3 WHITE BLEND
Type of Device
STOP COCK
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX 
MDR Report Key9297201
MDR Text Key191725296
Report Number9610847-2019-00672
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 12/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2021
Device Catalogue Number394900
Device Lot Number8338871
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2019
Date Manufacturer Received10/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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