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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 Known Impact Or Consequence To Patient (2692)
Event Date 04/06/2020
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.
 
Event Description
It was reported that the bd connecta¿ stopcock cap fell off before use.The following information was provided by the initial reporter: "the customer informs that recently several eaches of connecta stopcock with extension sets have had the same issue; drug administration cap falls of on its own from connecta stopcock.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 5/21/2020.H.6.Investigation: a device history record review was performed for provided lot number 9198831.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident and all inspections were found to be within specification.To aid in the investigation of this incident, one physical sample was shipped to the manufacturing facility for evaluation by our quality engineer team.Unfortunately, the returned sample has been misplaced and the investigative team is unable to locate the sample for investigation.If the sample is located, our quality team will complete a thorough sample investigation for the product; however, at this time a sample investigation could not be performed.
 
Event Description
It was reported that the bd connecta¿ stopcock cap fell off before use.The following information was provided by the initial reporter: "the customer informs that recently several eaches of connecta stopcock with extension sets have had the same issue; drug administration cap falls of on its own from connecta stopcock.".
 
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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 Key10002358
MDR Text Key195433193
Report Number9610847-2020-00141
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 08/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2022
Device Catalogue Number394995
Device Lot Number9198831
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2020
Date Manufacturer Received04/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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