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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 STOPCOCK
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA STOPCOCK Back to Search Results
Catalog Number 394995
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/02/2020
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.(b)(4).
 
Event Description
It was reported that the bd connecta¿ stopcock experienced a loose connection/separated/detachment with the stopcock/cap.The following information was provided by the initial reporter: the customer reports: the patient was receiving iv-cytostatic treatment and in the end of the treatment when flushing with saline the connecta stopcock extension tube came of from the patients iv cannula.The tube was pushed back in, but immediately fell of from luer lock connection.
 
Event Description
It was reported that the bd connecta¿ stopcock experienced a loose connection/separated/detachment with the stopcock/cap.The following information was provided by the initial reporter: the customer reports: the patient was receiving iv-cytostatic treatment and in the end of the treatment when flushing with saline the connecta stopcock extension tube came of from the patients iv cannula.The tube was pushed back in, but immediately fell of from luer lock connection.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2020-12-22 h6: investigation summary a device history record review was completed by our quality engineer team for provided lot number 0062461.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.To aid in the investigation of this incident, physical samples were returned for evaluation by our quality engineer team.Through examination of the samples, detachment between the tube and the fitting component was identified.Maintenance records were evaluated; however, there were no anomalies identified that could have resulted in this defect.See h10.
 
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Brand Name
BD CONNECTA 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
MX 
MDR Report Key10908604
MDR Text Key226768665
Report Number9610847-2020-00376
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2023
Device Catalogue Number394995
Device Lot Number0062461
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2020
Date Manufacturer Received02/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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