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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 394971
Device Problem Free or Unrestricted Flow (2945)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/25/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9092971.Medical device expiration date: 2022-03-31.Device manufacture date: 2019-05-07.Medical device lot #: 9116511.Medical device expiration date: 2022-03-31.Device manufacture date: 2019-05-14.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It has been reported that the bd connecta¿ stopcock has been found with air in the line during use.The following has been provided by the initial reporter: air flow through the extension valve during a bypass infusion.Another valve was installed, no consequence on the patient.
 
Event Description
It has been reported that the bd connecta¿ stopcock has been found with air in the line during use.The following has been provided by the initial reporter: air flow through the extension valve during a bypass infusion.Another valve was installed, no consequence on the patient.
 
Manufacturer Narrative
H.6.Investigation: a device history record review was performed for provided lot numbers 8338961, 9092971, and 9116511.The review did not reveal any detected quality issues during the production process that could have contributed to the reported incident.To further investigate this issue, one sample belonging to lot number 8338961 was received for evaluation by our quality team.The sample was used and the fitting was placed into the housing incorrectly, which prevented it from being disconnected from the device.The sample was functionally tested and the reported incident could not be replicated.Based on the investigation results, a manufacturing related cause could not be determined for this incident.
 
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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 Key9446313
MDR Text Key192053674
Report Number9610847-2019-00724
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
PMA/PMN Number
N/A
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 02/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2022
Device Catalogue Number394971
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No
Date Manufacturer Received11/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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