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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA

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BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA Back to Search Results
Catalog Number 320440
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Code Available (3191)
Event Date 10/01/2019
Event Type  Injury  
Manufacturer Narrative
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 foreign matter occurred after use with a bd vacutainer® push button blood collection set with pre-attached holder. The following information was provided by the initial reporter. "it was reported that a case of silicone bubbles post avastin injection was confirmed. Event description per attached email states: fyi: we have just confirmed another case of silicone bubbles post avastin injection. Injection date was oct (b)(6). The pt is booked for ongoing intraocular injections, right eye. We do not have the lot # of the syringes. " 1 of 2 complaints.
 
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Brand NameSYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA
Type of DeviceSYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer (Section G)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9324639
MDR Text Key166593866
Report Number1920898-2019-01295
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number320440
Device Lot Number9070598
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 Received10/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2019
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: 11/14/2019 Patient Sequence Number: 1
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