MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD SYRINGE 20ML LL S/C 50; PISTON SYRINGE

Catalog Number	303310
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2025
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 lot #unknown it was reported by customer that iv tech found a brown particulate in the inside of the barrel near the luer-lock of a 20ml bd syringe.She drew up fluid and pushed it out before she saw the particulate.Dose was wasted and remade.Verbatim: iv tech found a brown particulate in the inside of the barrel near the luer-lock of a 20ml bd syringe.She drew up fluid and pushed it out before she saw the particulate.Dose was wasted and remade.She did not keep the outside package of the syringe so unsure of the lot/expiration.Additional information provided: 1.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.This defect was noted prior to administering the dose, the dose was wasted and the remade.
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
One sample was received by our quality team for evaluation.Upon visual inspection, a brownish particle was visible near the cylinder bell.Therefore, the incident could be verified.A review of the internal manufacturing device records for the reported lot number was performed and no recorded quality problems or rejections related to this incident were found.The sample was sent for testing to determine what the particle was; however, the particle was too small for accurate testing and the origin could not be determined.Investigation into the manufacturing line was also conducted and no material similar to the one of the cylinders could be found.Operating personnel were still made aware of this event.This incident has been added to our database of reported incidents.
Event or Problem Description
No additional information.

• Brand Name: BD SYRINGE 20ML LL S/C 50
• 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: 21929398
• Report Number: 9614033-2025-00040
• Device Sequence Number: 18416038
• Product Code: FMF
• UDI-Device Identifier: 00382903033102
• UDI-Public: (01)00382903033102
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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: UNKNOWN
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown