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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNKNOWN INSULIN SYRINGE INSULIN SYRINGE WITH NEEDLE

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BECTON DICKINSON UNKNOWN INSULIN SYRINGE INSULIN SYRINGE WITH NEEDLE Back to Search Results
Catalog Number UNKNOWN
Device Problem Detachment Of Device Component (1104)
Patient Problem Abscess (1690)
Event Date 02/27/2017
Event Type  Injury  
Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. Complaints received for this device and reported condition will continue to be tracked and trended. If samples are received in the future the complaint will be reopened for further investigation. Unable to perform dhr check due to unknown lot number. Investigation conclusion: based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned. Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.
 
Manufacturer Narrative
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 in sections and the (b)(4) fda registration number has been used for the manufacture report number. 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 an unknown insulin syringe broke off in a consumer¿s lower abdomen. The consumer stated she developed an abscess. She went to the surgeon who ¿cut and packed¿ the area. There was no additional report of treatment or medical intervention.
 
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Brand NameUNKNOWN INSULIN SYRINGE
Type of DeviceINSULIN SYRINGE WITH 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
8015652845
MDR Report Key7261839
MDR Text Key194238124
Report Number2243072-2018-00072
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 consumer,other
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2017
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: 02/09/2018 Patient Sequence Number: 1
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