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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE WITH SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE SYRINGE WITH NEEDLE

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BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE WITH SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 305909
Device Problem Crack (1135)
Patient Problem Exposure to Body Fluids (1745)
Event Date 02/16/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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 during administration of omalizumab using a bd syringe with safetyglide¿ shielding hypodermic needle, the side barrel of the syringe cracked and the employee was splashed in the eye. Employee sought advice from occupational health but there was no report of medical interventions.
 
Manufacturer Narrative
Two loose 3ml syringes with eclipse needles with no packaging were received by bd canaan (lot number is unknown, catalog # was reported to be 305909). The two syringes were returned with residual medication inside barrel. Based on visual examination of the two returned samples, cracked barrel was observed on both samples from graduation mark 0- 1. No device history record review can be performed as lot number is unknown. Root cause could not be determined. No capa is required. Product defect is confirmed based on sample evaluation performed. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends.
 
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Brand NameBD SYRINGE WITH SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE
Type of DeviceSYRINGE WITH NEEDLE
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
8015652845
MDR Report Key7331285
MDR Text Key102119653
Report Number1213809-2018-00105
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K951254
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305909
Device Lot NumberUNKNOWN
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 Received02/16/2018
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: 03/12/2018 Patient Sequence Number: 1
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