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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 3ML LL W/NDL 20X1 RB

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BECTON DICKINSON SYRINGE 3ML LL W/NDL 20X1 RB Back to Search Results
Catalog Number 309578
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Unspecified Infection (1930)
Event Date 12/23/2019
Event Type  Injury  
Manufacturer Narrative
Device expiration date: unknown. Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown. 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.
 
Event Description
It was reported that an unspecified number of syringe 3ml ll w/ndl 20x1 rb were involved in serious injuries in the form of medical consultation resulting from a potential breach in sterility which was noted after use. It has been stated that multiple devices were used by the medical device operator after a potential sterility breach in the device packaging, resulting in "infection each time. " this has resulted in a review of the user facility's procedures, and an unspecified number of the patient's receipt of additional medical consultation/treatment. The results of this additional medical consultation/treatment have not been specified. The following information was provided by the initial reporter: material no: 309578 batch no: unknown. Event description: distributor has a customer that uses the 3ml syringe/needle 309578. He wants to know if the syringes are still sterile once the box is opened. He uses one every few days to administer a medication and reports getting an infection each time. Response with additional information: informed that the needle and inside of the syringe will remain sterile until used or until the cap is removed. Recommended he contact his nurse or physician and review the medication process using the syringe to ensure he is doing it properly. Informed caller that this information would be sent as a complaint during the daily case upload. Caller unable to provide any patient information.
 
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Brand NameSYRINGE 3ML LL W/NDL 20X1 RB
Type of DeviceSYRINGE
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 Key9587726
MDR Text Key188339565
Report Number2243072-2020-00029
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309578
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/23/2019
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: 01/14/2020 Patient Sequence Number: 1
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