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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON FEMALE LL ADAPTOR INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON FEMALE LL ADAPTOR INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 1029-104-090
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/26/2021
Event Type  malfunction  
Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is (b)(4). This site is an oem manufacturing site. Therefore, bd corporate headquarters in (b)(4) has been listed and the (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. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 0024076. Medical device expiration date: na. Device manufacture date: 2020-01-24. Medical device lot #: 0024077. Medical device expiration date: na. Device manufacture date: 2020-01-24. Medical device lot #: 0104784. Medical device expiration date: na. Device manufacture date: 2020-04-13. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported 1 female ll adaptor each from lots 0024076, 0024077, and 0104784 had damaged, bent tube caps. The following information was provided by the initial reporter: "for the in-0101183: ¿during a pre-use check, the customer noticed the cap was connected to the tube tip in a bent state. No patient injury. ¿ and for the in-0103020: ¿during a pre-use check, the customer noticed the cap was connected to the tube tip in a bent state. No patient injury. ¿ and for the in-0103130: ¿during a pre-use check, the customer noticed the cap was connected to the tube tip in a bent state. No patient injury. ¿".
 
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Brand NameFEMALE LL ADAPTOR
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12513544
MDR Text Key272725650
Report Number2243072-2021-02362
Device Sequence Number1
Product Code FPA
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 distributor,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number1029-104-090
Device Lot NumberSEE SECTION H.10.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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