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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; STOP COCK
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA STOPCOCK; STOP COCK Back to Search Results
Catalog Number 394995
Device Problem Leak/Splash (1354)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.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 at the connection site.The following information was provided by the initial reporter: leakage of the 3-way stopcock.Leakage occurred on the bottom/underside between the white and transparent piece of plastic.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/4/2021.H.6.Investigation: a device history record review was completed for provided lot number 0150048.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.To aid in the investigation of this issue, one non-bd product and one connecta product were returned for evaluation by our quality engineer team.Inspection and leakage testing was performed for the connecta product and no negative results were retrieved.Based on the investigation results, a cause related to the bd manufacturing process could not be determined for this incident.H3 other text : see h.10.
 
Event Description
It was reported that the bd connecta¿ stopcock experienced leakage at the connection site.The following information was provided by the initial reporter: leakage of the 3-way stopcock.Leakage occurred on the bottom/underside between the white and transparent piece of plastic.
 
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Brand Name
BD CONNECTA STOPCOCK
Type of Device
STOP COCK
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX 
MDR Report Key11069885
MDR Text Key223759534
Report Number9610847-2020-00430
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 03/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/30/2023
Device Catalogue Number394995
Device Lot Number0150048
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2021
Date Manufacturer Received03/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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