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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 394602
Device Problems Loose or Intermittent Connection (1371); Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/28/2023
Event Type  malfunction  
Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
 
Event Description
It was reported that the bd connecta¿ 3-way stopcock had a loose connection during use.This occurred with 10 stopcocks.The following information was provided by the initial reporter, translated from chinese: "the nurse manager reported that the nuts were found to be untightened during use.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 1152280 d4: medical device expiration date: 21-may-2024 h4: device manufacture date: 18-aug-2021.
 
Event Description
It was reported that the bd connecta¿ 3-way stopcock had a loose connection during use.This occurred with 10 stopcocks.The following information was provided by the initial reporter, translated from chinese: "the nurse manager reported that the nuts were found to be untightened during use.".
 
Event Description
Batch number supplied.The nurse manager reported that the nuts were found to be untightened during use.
 
Manufacturer Narrative
Our quality engineer inspected the 3 photos submitted for evaluation.The reported issue of loose component no leak was not confirmed upon inspection of the photos.The defect reported could not be seen in the sample photos supplied.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.We would be very interested in examining product that does not meet your expectations and our quality standards.Examination of the actual product involved may provide clarification as to the cause of the reported failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.H3 other text : see narrative below.
 
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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
MX 
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX  
Manufacturer Contact
jennifer suh
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key17733244
MDR Text Key323260195
Report Number9610847-2023-00259
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K974083
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number394602
Device Lot Number1152280
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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