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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 05/01/2016
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. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) has been used for the manufacture report number. The incident occurred in (b)(6) 2016. Results: a sample is not available for evaluation. A review of the device history record could not be performed as a lot number for this incident was not provided. 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.
 
Event Description
It was reported that in (b)(6) 2016, an unspecified bd insulin syringe was used by a patient's physician, dr. (b)(6), for an intraocular avastin injection to treat wet macular degeneration. After the procedure the patient noticed a number of small black spots in his field of vision. The patient noticed that the black spots remained constant throughout the summer and received two more treatments by another physician at (b)(6). The patient followed up with dr. (b)(6) in (b)(6) for additional treatment and mentioned the black spots to him. The patient was assured there was no danger from this and in all likelihood would dissipate with time. However, the patient states that he still has the black spots and they are nor dissipating. No medical interventions to treat the patient's affected vision were reported.
 
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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 Key6196846
MDR Text Key63065643
Report Number2243072-2016-00051
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
Report Date 12/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2016
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 Received12/08/2016
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: 12/21/2016 Patient Sequence Number: 1
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