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U.S. Department of Health and Human Services


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Catalog Number UNKNOWN
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 05/27/2020
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 (b)(4) has been listed in (b)(4) and (b)(4) fda registration number has been used for the manufacture report number. Medical device expiration date: unknown. The customer's address is unknown. (b)(6) has been used as a default. Device manufacture date: unknown. Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Capa is not required at this time.
Event Description
It was reported that unspecified bd¿ catheter was defective and disconnected from the hub. The following information was provided by the initial reporter: it was reported that iv unhooked from hub, cannula/needle too long and flimsy, blood flash, and connection between cannula hub and tubing extension disconnected due to inadequate dressing.
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Type of DeviceCATHETER
MDR Report Key12346053
MDR Text Key267459301
Report Number2243072-2021-02120
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial
Report Date 08/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2021
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