MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS LUER-LOK PRECISIONGLIDE; PISTON SYRINGE

Catalog Number	309642
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
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 10ml ll w/ndl 21x1 rb had foreign matter.The following information was provided by the initial reporter: material #:309642 & batch#:5093194.Verbatim: we received lot number 5093194 of syringe bd309642, and we noticed the apparent presence of powder inside the syringe (see attached photo).
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - foreign matter.Six samples and four photos of 10 ml ll syringes with needles (material 309642, batch 5093194) were received and evaluated.Inspection revealed multiple loose white spots within the fluid path of each syringe, which were accurately depicted in the submitted photos.Fourier transform infrared spectroscopy (ftir) analysis identified the foreign material as likely dried silicone, typically applied as a spray to the inner barrel surface during manufacturing.However, the origin of the defect could not be conclusively linked to the manufacturing site, and external storage or handling conditions may have contributed.As a result, no root cause could be determined, and corrective actions are not required.Additionally, a device history record review was completed for lot number 5093194, which showed no rejected inspections or quality issues during production that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured in trend reports and monitored monthly, with our business team regularly reviewing the data to identify any emerging trends.

• Brand Name: LUER-LOK PRECISIONGLIDE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22312171
• Report Number: 1213809-2025-00430
• Device Sequence Number: 8857827
• Product Code: FMF
• UDI-Device Identifier: 30382903096429
• UDI-Public: (01)30382903096429(11)250403(17)300331(10)5093194
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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: 309642
• Device Lot Number: 5093194
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown