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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS BD FEMALE LL ADAPTOR; INTRAVASCULAR ADMINISTRATION SET
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BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS BD FEMALE LL ADAPTOR; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 1029-104-090
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2023
Event Type  malfunction  
Event Description
It was reported while using bd female ll adaptor the device was damaged.There was no report of patient impact.The following information was provided by the initial reporter: reported a connector curved (deformed).
 
Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd female ll adaptor the device was damaged.There was no report of patient impact.The following information was provided by the initial reporter: reported a connector curved (deformed).
 
Manufacturer Narrative
H6: investigation summary a complaint of connector being deformed was received by bd.A photo was returned for investigation.In the photo, the defect of curved component was observed.The supplier of this component, the north american molding center (namc) was notified of this defect.A device history review was performed on both lot number 1348333 and 1348334 and there were no quality notifications for these lot numbers.A review of the pcc was conducted with zero impact/ change that would cause deformation on the mold.A review of the tooling and molding process was conducted with zero evidence on the impact that would cause the deformation.The review of the mold repair logs at namc was conducted with no actions recorded with any issue related to the deformed parts.Since no samples were available for review, the defect cannot be confirmed at this point.H3 other text : see h10.
 
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Brand Name
BD FEMALE LL ADAPTOR
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS
920 e 19th street
columbus NE 68601
Manufacturer (Section G)
BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS
920 e 19th street
columbus NE 68601
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key16573950
MDR Text Key312231952
Report Number1911916-2023-00160
Device Sequence Number1
Product Code FPA
UDI-Device Identifier70885403484386
UDI-Public(01)70885403484386
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number1029-104-090
Device Lot Number1348334
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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