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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INSULIN SYRINGE

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BECTON DICKINSON UNSPECIFIED BD INSULIN SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problem Contamination (1120)
Patient Problem Needle Stick/Puncture (2462)
Event Date 03/13/2017
Event Type  Injury  
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. Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Device manufacture date: unknown. Results: a sample is not available for evaluation. A review of the device history record could not be performed as a lot number was not provided for this incident. In the event that new, changed, or corrected information is obtained, a supplemental report will be filed. Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode. Udi #: unknown.
 
Event Description
It was reported that three nurses suffered contaminated needle stick injuries with an unspecified bd insulin syringe on unspecified dates. The nurses were evaluated by employee health and received an unspecified treatment. The treatment was not disclosed as it was deemed to be confidential by the initial reporter.
 
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Brand NameUNSPECIFIED BD INSULIN SYRINGE
Type of DeviceINSULIN SYRINGE
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 Key6448263
MDR Text Key71333925
Report Number2243072-2017-00024
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 other,user facility
Reporter Occupation
Type of Report Initial
Report Date 03/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2017
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 Received03/13/2017
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: 03/30/2017 Patient Sequence Number: 1
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