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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 Problems Leak/Splash (1354); Material Protrusion/Extrusion (2979)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/15/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that the bd connecta¿ stopcock experienced leakage and blood exposure/splash.It has not been specified whether the product defects were noted prior to, during, or after use.The following information was provided by the initial reporter: as reported by customer "using 3 way tap and blood/fluid squirted out the side of the tap.".
 
Event Description
It was reported that the bd connecta¿ stopcock experienced leakage and blood exposure/splash.It has not been specified whether the product defects were noted prior to, during, or after use.The following information was provided by the initial reporter: as reported by customer "using 3 way tap and blood/fluid squirted out the side of the tap.".
 
Manufacturer Narrative
H.6.Investigation: a device history record review was performed for provided lot number 9122559.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 issue, one picture sample and one physical sample were returned for evaluation by our quality engineer team.Due to covid-19 concerns, the used sample could not be investigated at this time.A thorough investigation utilizing other methodologies, available information, and the provided picture sample was completed to the best of our ability.Through examination the picture sample, leakage was observed.Unfortunately, an exact cause for the leakage could not be determined through the picture sample evaluation.There are current procedures in place to prevent and detect this type of defect.
 
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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 Key10119062
MDR Text Key195432807
Report Number9610847-2020-00169
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 06/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/30/2022
Device Catalogue Number394995
Device Lot Number9122559
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2020
Date Manufacturer Received05/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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