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

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.

• Brand Name: BD SYRINGE WITH SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE
• Type of Device: SYRINGE 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 Key: 7331285
• MDR Text Key: 102119653
• Report Number: 1213809-2018-00105
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903059097
• UDI-Public: 30382903059097
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951254
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305909
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 02/16/2018
• Supplement Dates FDA Received: 03/28/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Other