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

Catalog Number	309632
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 5ml ll w/ndl 21x1 rb needle hub had a hole was cracked / damaged.The following information was provided by the initial reporter: material # 309632 batch # 4325352.Rcc received a complaint via email.Operators have reported that some of the needles from this lot either have the green cap not intact to the plunger or there is damage to the green plastic housing the needle.Photos are attached as a reference.The site will continue to use this lot, however, the ones affected will be discarded.Product#: 309632 lot#: 4325352.
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
No additional information was provided.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - needle hub hole / cracked / damaged.One photo was provided to our quality team for investigation.It shows three needle assemblies without packaging or plastic shields.One assembly has the top part broken off, with the needle missing.The other two assemblies have damaged needle hubs.No additional defects or imperfections were observed.Based on the investigation and analysis of the photo sample, the reported symptom has been confirmed.Additionally, a device history record (dhr) review was completed for the provided lot number 4325352.The review 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.This information will be captured in trend reports and monitored monthly.Our business team regularly reviews the collected 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: 22324574
• Report Number: 1213809-2025-00433
• Device Sequence Number: 9023755
• Product Code: FMF
• UDI-Device Identifier: 30382903096320
• UDI-Public: (01)30382903096320(11)241120(17)291031(10)4325352
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• 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): 08/19/2025

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: 309632
• Device Lot Number: 4325352
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown