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

Catalog Number	303310
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 20ml ll s/c 50 had foreign matter.The following information was provided by the initial reporter: material # 303310, batch # 5015724.Verbatim: rcc received a complaint via email.Email(s) attached.We have found multi 20ml syringes that have issues.We found two so far with defective hole in the top and one with what appears to be plastic shards in the syringe itself.This is of great concern for our hospital please contact (b)(4) please.Customer responded on 18-jun.1.The event occurred on 06-12-2025.2- we do still have 2 defective syringes and i am including (b)(4) to help with where to mail the label and what department it should go to.
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
Four photos and two physical samples were received by our quality team for evaluation.Upon visual inspection of both the photos and the samples, it was observed that there was a foreign substance on the stopper; therefore, the reported incident could be verified.One sample showed the presence of foreign matter.According to the analysis performed by the physicochemical department using infrared spectroscopy, it was not possible to determine the origin of the material due to its size.A walkthrough of the involved production line was conducted without identifying materials with characteristics similar to the reported defect.Nevertheless, operational personnel will be notified about the event to reinforce vigilance in the area.A device history record review found there were no non-conformances associated with the foreign matter issue during the production of this batch.Since the foreign matter could not be identified, a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
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: 22342267
• Report Number: 9614033-2025-00066
• Device Sequence Number: 4901463
• Product Code: FMF
• UDI-Device Identifier: 00382903033102
• UDI-Public: (01)00382903033102(17)300131(10)5015724
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K151766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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: 5015724
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown