MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD SYRINGE 5ML LL SYRINGE ONLY MX BUN; PISTON SYRINGE

Catalog Number	302553
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 5ml ll syringe only mx bun had foreign matter.The following information was provided by the initial reporter translated from spanish to english: i notify the rejection of 300 pieces of the material 1012429 5 ml plastipak s/a luer lock syringe expiration 30jun27, lot 2208043, due to the presence of particles.During the inspection, 4 pieces were found to be defective due to the presence of foreign particles in the contents.Additional information provided: could you confirm that, of the 300 pieces, the pieces were identified in the same box? the pieces that presented the defect were identified in different boxes.Are additional photos of the needle related to the incident available for analysis? the input is available, if you require any additional photographs, they can be taken.Is the sample related to the reported event available for analysis? if so, indicate the quantity.4 pieces with quality defect (300 pieces to be returned).Name of sender: (b)(6).
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
Investigation results: four photos and five physical samples were received by our quality team for evaluation.Upon visual inspection, it was observed that there were two samples that have loose black particles in the cylinder and plunger and two samples that have loose particles with a metallic tone in the cylinder and plunger; therefore, the reported incident could be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections related to this incident were found.Based on the quality team's investigation, the material found on the syringes came from the manufacturing process.Actions were taken to mitigate the re-occurrence of this incident.This incident has been added to our database of reported incidents.

• Brand Name: BD SYRINGE 5ML LL SYRINGE ONLY MX BUN
• 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: 21514186
• Report Number: 9614033-2025-00012
• Device Sequence Number: 4449057
• Product Code: FMF
• UDI-Device Identifier: 07501073025530
• UDI-Public: (01)07501073025530(11)220823(17)270630(10)2208043
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K151766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: Other
• Device Catalogue Number: 302553
• Device Lot Number: 2208043
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown