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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. BD CONNECTA¿ 3-WAY STOPCOCK
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ 3-WAY STOPCOCK Back to Search Results
Catalog Number 394605
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem Death (1802)
Event Date 01/13/2019
Event Type  Death  
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 after the infusion from 9am to 3pm on (b)(6) 2019, a bd connecta¿ 3-way stopcock was found to have a crack, resulted in leakage.Patient had died on (b)(6) 2019, and death was diagnosed as natural death.
 
Manufacturer Narrative
Investigation summary: a device history review was conducted for lot number 8127973.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.A sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Based on reported record, the customer found a crack on housing component; however, we were not able to associate this crack to the mfg process.Quality records have been consulted for tracking and trending purposes but issues like this are not detected which means pretty low occurrence.Process (b)(4) were reviewed and there are proper controls in place to detect product malfunctions.Based on investigation results to date, root cause for manufacturing process cannot be determined.
 
Event Description
It was reported that after the infusion from 9am to 3pm on (b)(6) 2019, a bd connecta¿ 3-way stopcock was found to have a crack, resulted in leakage.Patient had died on (b)(6) 2019, and death was diagnosed as natural death.
 
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Brand Name
BD CONNECTA¿ 3-WAY STOPCOCK
Type of Device
STOPCOCK
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key8278453
MDR Text Key134131490
Report Number9610847-2019-00104
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2021
Device Catalogue Number394605
Device Lot Number8127973
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/11/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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