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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ CATHETER SAF-T-INTIMA 22G

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BECTON DICKINSON UNSPECIFIED BD¿ CATHETER SAF-T-INTIMA 22G Back to Search Results
Catalog Number UNKNOWN
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problems Abscess (1690); Unspecified Infection (1930)
Event Date 12/06/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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 fda registration number has been used for the manufacture report number. Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that unspecified bd¿ catheter saf-t-intima 22g was defective. This was discovered during use. The following information was provided by the initial reporter: for the moment, i have been able to collect only limited information on this incident (device not kept, lot and expiry unknown, conditions and installation date not found,. ). I'll come back to you when i'll have more information, and if the involvement of the catheter is proven plausible, i will not fail to communicate all the information to you in the form of an incident report that i will also transmit to the (b)(6), this incident being categorized as serious because it required surgical management to flatten a localized infectious abscess. Information received on december 19: i come back to you following the previous emails concerning an infection on saf t intima catheter. The analysis meeting revealed various points, which seemed to blame organisational and institutional shortcomings (lack of traceability of subcutaneous catheters due to the absence of appropriate computer protocols and information grids, traceability recommendations poorly known to healthcare personnel, etc. ). ) as well as risks related to the patient (at-risk terrain because it is polypathological, agitated and often tears off his infusions). The imputability of the material therefore seems very unlikely and in view of these various elements, since this is an isolated incident, the batch being unknown and the material not having been kept, this incident will not be the object of a declaration of materiovigilance.
 
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Brand NameUNSPECIFIED BD¿ CATHETER SAF-T-INTIMA 22G
Type of DeviceCATHETER
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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9534216
MDR Text Key174490576
Report Number2243072-2019-02918
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received12/06/2019
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

Patient Treatment Data
Date Received: 12/31/2019 Patient Sequence Number: 1
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