MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 1ML SYRINGE LUER-LOK TIP; PISTON SYRINGE

Model Number 309628

Device Problem Leak/Splash (1354)

Patient Problems Eye Injury (1845); Hemorrhage/Bleeding (1888); Visual Impairment (2138)

Event Date 05/17/2021

Event Type  Injury  

Manufacturer Narrative

Investigation summary: one photo was received.The photo showed the graphic side of a 1ml luer-lock syringe package from batch #1039878.Part of a rycroft package could also be seen in the photo.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.

Event Description

It was reported that the bd 1ml syringe luer-lok¿ tip experienced needle and syringe separation.The product defect resulted in a hemorrhage in the patient's eye.It has not been specified whether medical intervention was administered as a result.The following information was provided by the initial reporter: needle popped off luer lok syring whilst injecting eye casing, hemorrhage within patients eye.Potentially user error.

• Brand Name: BD 1ML SYRINGE LUER-LOK TIP
• Type of Device: PISTON 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12200531
• MDR Text Key: 262676225
• Report Number: 1213809-2021-00503
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096283
• UDI-Public: 30382903096283
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2021

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 Model Number: 309628
• Device Catalogue Number: 309628
• Device Lot Number: 1039878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other