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

Catalog Number	309642
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	06/03/2025
Type of Reportable Event	Malfunction
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 # 5015056 verbatim: rcc received a complaint via phone.Ref 309642 lot unknown issue: black ring around syringes when package is opened, appears to be in the fluid pathway.Doe: 03june2025.No pt harm samples yes qty: all three cases.Note: supplier is emailing pictures and original email notification from customer.Supplier is seeking credit, please include supplier in all communication.
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
(b)(4)- supplemental mdr - foreign matter.A total of one hundred one samples and one photo of 10 ml ll syringes (material 309642, batch 5015056) were evaluated as part of the investigation.While all syringes were fully assembled, one was received with an open seal and the remaining 100 were sealed.Visual inspection revealed that forty-one syringes exhibited a full or partial ink ring near the barrel roof, a condition that does not conform to product specifications, while the remaining sixty syringes showed no observable defects.The photo submitted corroborated the physical findings.The potential root cause of the ink ring defect is associated with the marking process.As a corrective action, a quality alert will be issued to the manufacturing plant.Furthermore, a device history record review was completed for provided lot number 5015056.A review showed no rejected inspections or quality issues during the 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 on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.

• 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: 22302709
• Report Number: 1213809-2025-00424
• Device Sequence Number: 18199384
• Product Code: FMF
• UDI-Device Identifier: 30382903096429
• UDI-Public: (01)30382903096429
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• 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): 08/12/2025

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: 309642
• Device Lot Number: 5015056
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown