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

Catalog Number	303310
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material #303310, lot #4114045, 4261566.It was reported that the bd luer-lok had foreign matter.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.We have a 20ml syringe that has spots inside of it.Further information provided: ¿ 1.In the medsun form mentioned that the date of the event as ¿jan-2025¿.Could you please specify the exact date when the reported issue happened? 1.9.2025 2.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.None 3.The medsun form indicates that the sample has been ¿returned to manufacturer (yes).¿ could you please confirm whether the sample has already been returned to bd? if so, please share the tracking number.1.13 emailed productcomplaints@bd.Com.01.17 fedex trk# (b)(4).
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
The samples under the tracking number mentioned by the customer were previously received for related complaint, (b)(4).The results from that investigation were completed and sent to the customer on march 11th, 2025.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.10 retention samples from lot: 4261566 and lot: 4114045 were requested for analysis, and were found to be compliant, meaning they did not present any defects.A root cause could not be determined for the lots mentioned in this complaint.However, a notification was made to the operating staff about this event.
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: 21599722
• Report Number: 9614033-2025-00017
• Device Sequence Number: 18209235
• Product Code: FMF
• UDI-Device Identifier: 00382903033102
• UDI-Public: (01)00382903033102(11)240613(17)290430(10)4114045
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: 4114045
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown