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U.S. Department of Health and Human Services

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

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BECTON DICKINSON UNKNOWN BD¿ INSULIN SYRINGE/NEEDLE INSULIN SYRINGE WITH NEEDLE Back to Search Results
Catalog Number UNKNOWN
Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/08/2017
Event Type  malfunction  
Manufacturer Narrative
Additional information, the original mdr used the bd awareness date (b)(6) 2017 as the date of event, since it was unknown. The date of event is now known. Date of event: (b)(6) 2017.
 
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. (b)(4). Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. (b)(6). Device manufacture date: unknown. Results: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. A device history review was not conducted because a lot number could not be determined. Conclusion: bd was unable to confirm the customer¿s indicated failure mode because no samples or photos were received to confirm the stated defect.
 
Event Description
It was reported that the needle of an unknown bd¿ insulin syringe/needle detached and remained in the patients skin. There was no report of medical intervention.
 
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Brand NameUNKNOWN BD¿ INSULIN SYRINGE/NEEDLE
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 Key7161749
MDR Text Key257002635
Report Number2243072-2017-00420
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 02/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2018
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
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2017
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: 01/03/2018 Patient Sequence Number: 1
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