MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD LUER-LOK; PISTON SYRINGE

Catalog Number	303310
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
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 20ml ll s/c 50 barrel cracked.The following information was provided by the initial reporter: material#: 303310.Batch#: 4319956.Rcc received a complaint via email.Plastic syringe cracked as technician was drawing up chemo medication.Leading to drug leaking out of closed system transfer system.Product#: 303310.Lot #: 4319956.
Additional Manufacturer Narrative
Additional information added to b5.Investigation results: two photos were received by our quality team for evaluation.In the photos, a crack can be seen at the level of the number 15 on the scale, which could result in leakage.The reported incident could be verified.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation, the possible root cause for this incident could be traced to manufacturing.When the barrel and plunger are misaligned during assembly, a jam can occur in the line.As a consequence, mechanical damage to both components caused by impact and friction can result in cracking of the barrel and can generate the leakage defect.Actions have been put in place as a result of this report.
Event or Problem Description
Additional information: where was the crack? ¿ the barrel and barrel flange.Which closed system was the syringe attached to? - chemolock.Did the syringe leak where the crack was - yes some liquid leaked out the syringe barrel where the syringe was cracked and the closed system also had a leak ¿ no the chemolock pieces behaving as usual.Chemo likely leaking out the side of the cracked syringe.

• Brand Name: BD LUER-LOK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23665876
• Report Number: 9614033-2025-00116
• Device Sequence Number: 18743468
• Product Code: FMF
• UDI-Device Identifier: 00382903033102
• UDI-Public: (01)00382903033102(17)291130(10)4319956
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K151766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 303310
• Device Lot Number: 4319956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown