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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML LL W/O DN PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML LL W/O DN PISTON SYRINGE Back to Search Results
Model Number 309628
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem Visual Impairment (2138)
Event Date 10/16/2019
Event Type  Injury  
Manufacturer Narrative
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 7291739. Medical device expiration date: 2022-09-30. Device manufacture date: 2017-11-02. Medical device lot #: 8057806. Medical device expiration date: 2023-02-28. Device manufacture date: 2018-04-17. 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 unspecified number of syringe 1ml ll w/o dn experienced foreign matter contamination which was noted prior to use. The reported defect led to a serious injury in the form of vision impairment/ocular inflammation. The following information was provided by the initial reporter: material no. : 309628 batch no. : 7291739, 8057806. Complaint 1 of 3: this complaint is for 1ml syringe cat # 309628. Per complaint: we are faced with a technical complaint where the doctor observed that after ocular injection silicone or silicon like droplets were present in the eye of the patient which claimed in 3 of 4 cases about eye inflammation. Additionally the doctor noticed "small metallic, irregularly shaped shimmering flakes floating in the anterior vitreous". The auxiliary material was provided from distributor and manufactured at bd. They observed after ocular injection using the syringes and needles provided from bd , silicon oil droplets and metallic flakes in the eye of the patient. These observations were connected with an inflammation of the eyes of patients. Furthermore we were notified that it can be a general issue that silicone oil droplets are extracted from the syringe onto the product dosed.
 
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Brand NameSYRINGE 1ML LL W/O DN
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9728173
MDR Text Key192254989
Report Number1213809-2020-00118
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K941562
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 03/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number309628
Device Catalogue Number309628
Device Lot NumberSEE H.10
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 Received01/30/2020
Was Device Evaluated by Manufacturer? Yes
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: 02/19/2020 Patient Sequence Number: 1
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