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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¿ PLUS STOPCOCK
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ PLUS STOPCOCK Back to Search Results
Catalog Number 394900
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2021
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 male lock on the bd connecta¿ plus stopcock was damaged.The following information was provided by the initial reporter, translated from (b)(6): "the customer has confirmed that the male luer lock was damaged.".
 
Event Description
It was reported that the male lock on the bd connecta¿ plus stopcock was damaged.The following information was provided by the initial reporter, translated from (b)(6): "the customer has confirmed that the male luer lock was damaged.".
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation: sample was returned and photos were forwarded to the manufacturing facility.Our quality engineer inspected the 5 photos submitted for evaluation.The reported issue was confirmed upon inspection of the photos.Bd determined that there is a possibility of this defect occurring as the final product is transferred to the packaging station under irregular conditions.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
Event Description
It was reported that the male lock on the bd connecta¿ plus stopcock was damaged.The following information was provided by the initial reporter, translated from japanese: "the customer has confirmed that the male luer lock was damaged.".
 
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Brand Name
BD CONNECTA¿ PLUS 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13306512
MDR Text Key285768652
Report Number9610847-2022-00012
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2023
Device Catalogue Number394900
Device Lot Number0308601
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2020
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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