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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD¿ FEMALE ADAPTER INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON BD¿ FEMALE ADAPTER INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 1029-104-090
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/27/2021
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. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 1263568, medical device expiration date: na, device manufacture date: 2021-09-20. Medical device lot #: 1291851, medical device expiration date: na, device manufacture date: 2021-10-18. 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 that foreign particles were found on 19 bd¿ female adapters from lot 1263568, and 5 adapters from lot 1291851 during an inspection. The following information was provided by the initial reporter: "at incoming inspection it has been reported via (b)(4) that the material has contamination. According to the s31-090 rev 102. Sec. 5 "cleanliness" the parts shall be free of embedded particles exceeding 0. 2 mm² in size. Parts shall be free of loose or adherent particulate exceeding 0. 04 mm² in size and the parts measure with tappi chart states 2. 5 mm². ".
 
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Brand NameBD¿ FEMALE ADAPTER
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13291532
MDR Text Key286951634
Report Number2243072-2021-03133
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1029-104-090
Device Lot NumberSEE SECTION H10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/11/2022
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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