Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ 3-WAY STOPCOCK Back to Search Results
Catalog Number 394602
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: since no photos or samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformance's associated with this issue during the production of this batch.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.
 
Event Description
It was reported that the bd connecta¿ 3-way stopcock cracked and leaked during the spinal epidural procedure.The following information was provided by the initial reporter, translated from (b)(6): "in 2021, the patient had an intrauterine pregnancy and underwent a cesarean section under combined spinal-epidural anesthesia.During the operation, it was found that the intravenous indwelling needle and the three-way junction continued to leak fluid, and the inspection revealed that the three-way interface was cracked, and the leakage of the liquid medicine could easily cause the medicine.Insufficient effect, affecting the treatment effect, immediately replace the new one.".
 
Event Description
It was reported that the bd connecta¿ 3-way stopcock cracked and leaked during the spinal epidural procedure.The following information was provided by the initial reporter, translated from (b)(6): "in (b)(6) 2021, the patient had an intrauterine pregnancy and underwent a cesarean section under combined spinal-epidural anesthesia.During the operation, it was found that the intravenous indwelling needle and the three-way junction continued to leak fluid, and the inspection revealed that the three-way interface was cracked, and the leakage of the liquid medicine could easily cause the medicine.Insufficient effect, affecting the treatment effect, immediately replace the new one.".
 
Manufacturer Narrative
Investigation summary: since no photos or samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformance's associated with this issue during the production of this batch.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13048159
MDR Text Key285761905
Report Number9610847-2021-00604
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeCH
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
Report Date 12/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/29/2024
Device Catalogue Number394602
Device Lot Number1061606
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/23/2021
Initial Date FDA Received12/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-