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

Catalog Number	309642
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.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 needle pulled out of the hub.The following information was provided by the initial reporter: material # 309642 batch # 5064172 verbatim: rcc received a complaint via email.Email(s) attached contact name: **** contact number: **** contact email (if available): item(s): 309642 lot(s): 5064172 date incident occurred:ongoing for a couple of weeks was the patient impacted? if yes, describe: when removing the cap, the needle falls off.Has tried to twist/tighten before removing cap, but needle still falls off.It¿s not every needle, but this week has been 7 is a sample available?: yes customer request?: customer needs replacements to be able to take medications additional information received on 31jul2025: customer called on 31jul2025 with her email and physical address.She states that she did get poked as a result of the defect.No medical attention was needed.She is requesting a return label and kit to be sent to her address.Please make sure to include her email address in the latest follow up with return label (b)(6).
Additional Manufacturer Narrative
(b)(4)- supplemental mdr - needle pulled out of hub.Four samples were provided to the quality team for investigation.A visual inspection of all samples revealed no observable defects or imperfections.The plastic shield was removed from each sample while still assembled to the syringe, and the needle assembly remained securely in place, indicating no functional anomalies.Based on the investigation and sample analysis, the reported symptom could not be confirmed.Furthermore, a device history record review was completed for provided lot number 5064172.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: 22723379
• Report Number: 1213809-2025-00525
• Device Sequence Number: 8344489
• Product Code: FMF
• UDI-Device Identifier: 00382903096428
• UDI-Public: (01)00382903096428(17)300228(10)5064172
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: Lay User/Patient
• Device Catalogue Number: 309642
• Device Lot Number: 5064172
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown