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

Catalog Number	309658
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe 3ml ll euro 200 s/c had a syringe needle connectivity issue.The following information was provided by the initial reporter: it was reported that during an eye surgery, the needle came loose despite the luer-loc connector.The patient sustained an eye injury, resulting in a laceration of the iris root.Additional information provided: 1.) during cataract surgery, the anterior chamber was flushed due to bleeding.The remaining surgical steps were uneventful ¿ diamox 250mg was administered upon discharge to reduce intraocular pressure.2.) close monitoring was performed in the outpatient clinic.A brief increase in intraocular pressure on the first post-operative day was treated with diamox and cosopt (tablets and gtt, no iv therapy necessary).3.) no further medication was required.The patient, with mild corneal edema (post-operative), was referred to a specialist for further follow-up.Her final visual acuity was 0.6.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation forty-six samples of 3 ml ll syringes (part number 309658) were received and inspected.All samples were fully assembled and packaged, and no issues related to the reported defect were observed.The samples conform to product specifications.It is recommended to hand-tighten the needle onto the syringe prior to use.Furthermore, a device history record review was completed for provided lot number 4352865.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• Brand Name: BD PLASTIPAK LUER-LOK
• Common Device Name: 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23491624
• Report Number: 1213809-2025-00706
• Device Sequence Number: 8689422
• Product Code: FMF
• UDI-Device Identifier: 00382903096589
• UDI-Public: (01)00382903096589(11)241217(17)291130(10)4352865
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: Health Professional
• Device Catalogue Number: 309658
• Device Lot Number: 4352865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown