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

Catalog Number	309632
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 5ml ll w/ndl 21x1 rb luer was cracked / damaged / deformed.The following information was provided by the initial reporter: material: 309632, batch#: 5063044.Verbatim: rcc received a complaint via email.The 5 ml leur lock syringes were breaking at the leur tip of the syringe (the hub).The inner piece of the leur tip would break/crack, preventing some patients from being injected with their doses.Additionally, operators drawing doses had multiple instances of this occurring prior to leaving the pharmacy.Product#: 309632, lot#: 5063044.Additional information received on 4-june-2025: events that affected patient's doses occurred on (b)(6) 2025.I don't have specific dates for the syringes caught before they were dispensed.Please see attached photo of patient dose affected 2 patients were able to get their doses.Another had to get their scan rescheduled.No patient harm/injury has been reported.
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 - luer cracked / damaged / deformed a photograph of a 5 ml luer-lok syringe was received and reviewed.The image depicts a fully assembled loose syringe covered with a white cap, where a portion of the syringe tip is visibly broken and remains lodged inside the cap.The condition observed is non-conforming per product specification.Potential root cause for the broken tip defect is associated with the assembly process.Furthermore, a device history record review was completed for provided lot number 5063044.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: 22180627
• Report Number: 1213809-2025-00385
• Device Sequence Number: 12888181
• Product Code: FMF
• UDI-Device Identifier: 30382903096320
• UDI-Public: (01)30382903096320(11)250304(17)300228(10)5063044
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 08/01/2025

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: 5063044
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown