MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL Luer-Lok; Syringe, Piston

Catalog Number	309653
Medical Device Problem Codes	Fluid/Blood Leak (1250); Separation Problem (4043)
Health Effect - Clinical Code	Emotional Changes (1831)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, syringe 50ml ll tip 1ml, the plunger became detached during the preparation of a hazardous medication, causing leak and staff exposure.The following was provided by the initial reporter: this letter serves to formally report a complaint regarding the bd luer lok 50 ml syringe, lot numbers 6134989 and 6099628 (lots in circulation at the time of the incident).The plunger became detached during the preparation of a hazardous medication.The preparation is performed in a closed system, and the medication is drawn from a 2 ml vial.This is the first time such an incident has occurred.While pulling back on the plunger to withdraw bcg, the plunger came completely out of the syringe barrel.The plunger's removal caused a spill of hazardous medication, exposing personnel to significant risks.Fortunately, the preparer was wearing appropriate protective equipment, and the spill was quickly contained.For this preparation, the 60 ml syringe used (graduated up to 50 ml) is prefilled with 50 ml of saline.The closed system transfer device is then attached to the syringe tip and to the bcg vial.Next, 2 ml of saline is injected into the vial to dilute the powdered medication.The liquid is then aspirated from the vial (2 ml) to complete the preparation.Under normal circumstances, when preparing medication from a vial using a transfer device attached to the syringe tip, the plunger does not come out.Even without a closed-system device, a very strong pulling force would normally be required to completely dislodge the plunger from the body of a 50 ml syringe because of the retaining ring.Three hypotheses are being considered to explain this incident: additional information: could you please provide an exact date of the event ? 10072026.We cannot share a sample because it is a biohazard drug.However, we took a photo of the packaging of the two batches in circulation, as well as a photo of a similar assembly but with a 5 ml vial (while the bcg is in a 2 ml vial) describe any harm, injury, complication or negative outcome experienced by the patient as a result of the event.Patients: postponement of bcg treatments for two patients a week later.The two patients are experiencing the disadvantages of preparing for treatment and have moved.Staff: staff exposure to bcg: stress, emergency room visit, microbiology testing and follow up being evaluated.Waste of time for the pharmacy team, incident management.Services: shutdown of the oncology pharmacy services for the management of spills and decontamination.Emergency room decontamination service.Emergency consultation with infection protection and control services.Emergency consultation with the on call microbiologist.Hardware: loss of medication bacille calmette guerin (bcg).Loss of preparation equipment.Use of spill management equipment.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

• Brand Name: Luer-Lok
• Common Device Name: Syringe, Piston
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; +1(847)393-5694
• MDR Report Key: 50132945
• Report Number: 1911916-2026-00397
• Device Sequence Number: 10528309
• Product Code: FMF
• UDI-Device Identifier: 00382903096534
• UDI-Public: (01)00382903096534(10)6099628
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 309653
• Device Lot Number: 6099628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2026
• Supplement Date Received by Manufacturer: 09/06/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2026
• 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