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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 Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2019
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.Initial reporter phone #: 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.
 
Event Description
It was reported that during use leakage occurred through the port with a bd connecta¿ stopcock.The following information was provided by the initial reporter: after surgery the patient was being moved to recovery.It was noticed that there was leakage from the port of connecta.This was then disconnected and a new connecta was used.No harm to patient or clinician, however there could have been.High risk of an air embolism if this had not been noticed.The lot no was not noted as this occurred after surgery and the packaging had been disposed of.
 
Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.This is a duplicate of mfr report # 9610847-2019-00647 that was reported for malfunction.H3 other text: see h.10.
 
Event Description
It was reported that during use leakage occurred through the port with a bd connecta¿ stopcock.The following information was provided by the initial reporter: after surgery the patient was being moved to recovery.It was noticed that there was leakage from the port of connecta.This was then disconnected and a new connecta was used.No harm to patient or clinician, however there could have been.High risk of an air embolism if this had not been noticed.The lot no was not noted as this occurred after surgery and the packaging had been disposed of.
 
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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 Key9355004
MDR Text Key191727355
Report Number9610847-2019-00690
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 01/15/2020
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 Catalogue Number394971
Device Lot NumberUNKNOWN
Initial Date Manufacturer Received 11/01/2019
Initial Date FDA Received11/21/2019
Supplement Dates Manufacturer Received11/01/2019
Supplement Dates FDA Received01/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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