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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 Consequences Or Impact To Patient (2199)
Event Date 11/19/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
 
Event Description
It was reported that the bd connecta¿ stopcock cap detached and leakage occurred during use.The following information was provided by the initial reporter: "as i had a personnel appointment there and asked questions about the products they were using, they shared with me that when they use the bd connecta at the radiology department, they estimate that in 80% of cases, the cap on the right hand side pops off, with some leakage occurring at times.As this was not a specific patient situation, i wanted to let you know directly.".
 
Event Description
It was reported that the bd connecta¿ stopcock cap detached and leakage occurred during use.The following information was provided by the initial reporter: "as i had a personnel appointment there and asked questions about the products they were using, they shared with me that when they use the bd connecta at the radiology department, they estimate that in 80% of cases, the cap on the right hand side pops off, with some leakage occurring at times.As this was not a specific patient situation, i wanted to let you know directly.".
 
Manufacturer Narrative
H6: investigation summary as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.See h.10.
 
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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 Key11028778
MDR Text Key226857436
Report Number9610847-2020-00419
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 01/08/2021
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 Health Professional
Device Catalogue Number394995
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/19/2020
Initial Date FDA Received12/17/2020
Supplement Dates Manufacturer Received01/08/2021
Supplement Dates FDA Received01/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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