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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD PEN NEEDLE

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BECTON DICKINSON UNSPECIFIED BD PEN NEEDLE Back to Search Results
Catalog Number UNKNOWN
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem Needle Stick/Puncture (2462)
Event Date 09/21/2020
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 (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: no samples or photos were returned for analysis.No dhr review can be carried out as lot number is unknown.Based on an evaluation of severity and occurrence it was determined that no corrective action is required at this time.
 
Event Description
It was reported that an employee pricked himself with an unspecified bd¿ pen needle after use on the patient.The following information was provided by the initial reporter: we recently had 2 needle-stick accidents where an employee pricked himself on a safe insulin pen needle.The needle-stick injury occurred after the insulin was administered to the patient.The needle was sticking out of the sleeve.I don't know if this is due to a batch problem or misuse of it.There are still problems with the safe handling of these needles to this day.The administration of the insulin still causes problems, it is not certain that the patient has received the amount of insulin (not visible or audible).
 
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Brand Name
UNSPECIFIED BD PEN NEEDLE
Type of Device
PEN NEEDLE
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 Key10611067
MDR Text Key209334879
Report Number2243072-2020-01541
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/21/2020
Initial Date FDA Received09/30/2020
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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