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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD CATHENA IV INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON UNSPECIFIED BD CATHENA IV INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number UNKNOWN
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2022
Event Type  malfunction  
Event Description
It was reported that 1 unspecified bd cathena iv had needle retraction issues. The following information was provided by the initial reporter: the user reported starting an iv on an outpatient using a bd cathena iv and retracted the needle back the safety mechanism on the end of the needle failed so that the end of the needle was exposed.
 
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 and the (b)(4) fda registration number has been used for the manufacture report number. Medical device expiration date: unknown. The customer's address is unknown. Usa has been used as a default. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Medical device manufacture date: unknown.
 
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Brand NameUNSPECIFIED BD CATHENA IV
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 Key14322051
MDR Text Key291218282
Report Number2243072-2022-00645
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/09/2022
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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