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	09/18/2025
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 lot # 5069180   verbatim: rcc received a complaint via email.Email(s) attached.My pharmacy technician was drawing up a dose of injectable into a 20cc bd syringe and fluid started leaking out the side of the syringe.Upon close inspection, it was discovered that there was a small crack in the barrel of the syringe.The preparation was discarded and new supplies and drug were obtained.There was no harm to the patient, only wasted drug for the pharmacy.Item# 303310 batch# 5069180 customer response on 24-oct-2025: the sample is no longer available.It was inadvertently discarded by our cleaning staff after several weeks of sitting on my desk.I do have a photo - please see the attached image.
Additional Manufacturer Narrative
Correction: a0504 added.Investigation results: one photo was received by our quality team for evaluation.A possible crack could be observed in the photo which could result in the leakage; therefore, 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.An action plan been put in place as a result of this report.This incident has been added to our database of reported incidents.
Event or Problem Description
No additional information.

• 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: 23501576
• Report Number: 9614033-2025-00109
• Device Sequence Number: 8965865
• Product Code: FMF
• UDI-Device Identifier: 00382903033102
• UDI-Public: (01)00382903033102(17)300331(10)5069180
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,User Facility
• 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: 5069180
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 77 KG