MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ DISPOSABLE SYRINGE

Catalog Number 309628

Device Problem Leak/Splash (1354)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Occlusion (1984); Retinal Detachment (2047)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported with the use of the bd luer-lok¿ disposable syringe there was an issue with endophthalmitis, inflammation and infection of their left eye that results in blindess.Patient was further diagnosed with leakage, hemorrhages, central retinal artery occlusion and a retinal detachment.

Manufacturer Narrative

Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.We would be very interested in examining product that does not meet your expectations and our quality standards.A device history record review could not be performed as lot number is unknown.A corrective and preventive action were initiated to address a similar issue which was previously received.A similar issue was investigated and the following was initiated: capa 323013.(b)(4).

Event Description

It was reported with the use of the bd luer-lok¿ disposable syringe there was an issue with endophthalmitis, inflammation and infection of their left eye that results in blindess.Patient was further diagnosed with leakage, hemorrhages, central retinal artery occlusion and a retinal detachment.

• Brand Name: BD LUER-LOK¿ DISPOSABLE SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7974064
• MDR Text Key: 123985884
• Report Number: 1213809-2018-00665
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096283
• UDI-Public: 30382903096283
• Combination Product (y/n): N
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309628
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability