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

Catalog Number	305909
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	02/16/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.

• Brand Name: BD SYRINGE WITH SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7331285
• Report Number: 1213809-2018-00105
• Device Sequence Number: 18869865
• Product Code: FMF
• UDI-Device Identifier: 30382903059097
• UDI-Public: 30382903059097
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 305909
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other