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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 07/12/2019
Event Type  malfunction  
Manufacturer Narrative
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 containing air bubbles during use.The following has been provided by the initial reporter: a lot of air bubbles notices in many extension tubes even though 3-way stopcock is closed.
 
Manufacturer Narrative
H.6.Investigation: bd was not able to confirm the failure mode because samples or picture were not provided which are necessary to perform a better investigation.Based on investigation results to date, root cause for manufacturing process cannot be determined.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.There were no nonconformance(s), capa¿s or abnormal conditions noted at the time of production.At the time of the dhr review, there were no changes to the process and/or equipment that would have affected the manufacturing of the device.
 
Event Description
It has been reported that the bd connecta¿ stopcock has been found containing air bubbles during use.The following has been provided by the initial reporter: a lot of air bubbles notices in many extention tubes even though 3-way stopcock is closed.
 
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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 Key8837140
MDR Text Key153819412
Report Number9610847-2019-00484
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 08/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2021
Device Catalogue Number394971
Device Lot Number8215999
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/12/2019
Initial Date FDA Received07/29/2019
Supplement Dates Manufacturer Received07/12/2019
Supplement Dates FDA Received08/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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