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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 395095
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2022
Event Type  malfunction  
Event Description
It was reported that the bd connecta¿ stopcock experienced damaged tubing.The following information was provided by the initial reporter: nursing staff identified before procedure.Extension line is damaged & seems to be very short length.
 
Manufacturer Narrative
Initial reporter addr 1: (b)(6).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 summary our quality engineer inspected the 1 picture submitted for evaluation.The reported issues of component damage - no leak and adapter / connector defective / damaged were confirmed upon inspection of the photo and review of maintenance records.Upon review of the sample photo the defects reported were observed.Maintenance records also showed adjustments that could contributed to the defect.Bd determined that the cause of the failure was associated to the manufacturing process.This problem was identified and corrected.Production records were reviewed, and this batch was in compliance with our product specification requirements.
 
Event Description
It was reported that the bd connecta¿ stopcock experienced damaged tubing.The following information was provided by the initial reporter: nursing staff identified before procedure.Extension line is damaged & seems to be very short length.
 
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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 
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 Key15482096
MDR Text Key306421853
Report Number9610847-2022-00366
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeIN
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 11/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number395095
Device Lot Number1308099
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2021
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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