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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON PEN II MYLAN 3.0ML PEN NEEDLE

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BECTON DICKINSON PEN II MYLAN 3.0ML PEN NEEDLE Back to Search Results
Catalog Number 47314378
Device Problem Difficult to Advance (2920)
Patient Problem No Information (3190)
Event Date 04/05/2019
Event Type  malfunction  
Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is (b)(4). This site is an oem manufacturing site. 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: n/a. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that 2 pen ii mylan 3. 0ml devices had difficult plunger movement during the injection, though the patient reportedly received the "full benefit" from them. The following information was provided by the initial reporter: "pen device stick and make a "clunk" sound as it injected; arrows were lined up. Pt experienced full benefit from injection. So far, this happened 2 times. ".
 
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Brand NamePEN II MYLAN 3.0ML
Type of DevicePEN 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 Key8540567
MDR Text Key145510429
Report Number2243072-2019-00767
Device Sequence Number1
Product Code FMF
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 distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number47314378
Device Lot Number16218001
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 Received04/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/18/2016
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: 04/23/2019 Patient Sequence Number: 1
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