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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD CONNECTA STOPCOCK
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BECTON DICKINSON UNSPECIFIED BD CONNECTA STOPCOCK Back to Search Results
Catalog Number UNKNOWN
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/25/2021
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed in sections and (b)(4) fda registration number has been used for the manufacture report number.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 6 unspecified bd connecta¿ stopcocks leaked and 3 had foreign matter on the caps.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "it was reported via post market survey that the clinician encountered occurrences of leakage (6) and foreign matter on bd plug (3).".
 
Event Description
It was reported that 6 unspecified bd connecta¿ stopcocks leaked and 3 had foreign matter on the caps.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "it was reported via post market survey that the clinician encountered occurrences of leakage (6) and foreign matter on bd plug (3).".
 
Manufacturer Narrative
H.6.Investigation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Dhr could not be performed due to unknown lot#.The complaint can't be confirmed and the root cause is undetermined.H3 other text : see h.10.
 
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Brand Name
UNSPECIFIED BD CONNECTA STOPCOCK
Type of Device
STOPCOCK
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11346428
MDR Text Key266711164
Report Number2243072-2021-00380
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup
Report Date 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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