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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INTROSYTE¿ INTRODUCER CATHETER INTRODUCER

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BECTON DICKINSON UNSPECIFIED BD INTROSYTE¿ INTRODUCER CATHETER INTRODUCER Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Hematoma (1884)
Event Date 03/31/2022
Event Type  Injury  
Event Description
It was reported that the patient experienced an infection that occurred after the unspecified bd introsyte¿ introducer was used on them, and had to have medical intervention as a result. No further information was provided. The following information was provided by the initial reporter: "infection (within 24-48 hours after insertion of the introducer) - 3" "it was reported that infection (within 24-48 hours after insertion of the introducer) resulting in patient or clinician injury that required medical or surgical intervention when using the bd introsyte¿ introducers to facilitate the placement of indwelling central venous catheters".
 
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 franklin lakes, nj has been listed in sections d. 3. And g. 1. And the franklin lakes 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. Medical device expiration date: unknown. The customer's address is unknown. New jersey, usa has been used as a default. Device manufacture date: unknown. Investigation summary: as no physical sample, valid part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed. Based on the limited investigation results, a cause for the reported incident could not be determined. Examination of the product involved may provide clarification as to the cause for the reported failure. Complaints received for this device and reported condition will continue to be tracked and trended. Our quality team regularly reviews the collected data for identification of emerging trends.
 
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Brand NameUNSPECIFIED BD INTROSYTE¿ INTRODUCER
Type of DeviceCATHETER INTRODUCER
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 Key15118638
MDR Text Key296758180
Report Number2243072-2022-01007
Device Sequence Number1
Product Code DYB
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2022
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

Patient Treatment Data
Date Received: 07/28/2022 Patient Sequence Number: 1
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