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	06/20/2025
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#:5063045.Rcc received a complaint via email." on friday, (b)(6) 2025, a dose contamination incident was reported at the xxxxxxxxxxxxxxxxx.The contamination occurred due to a broken syringe, which compromised the connection and caused the dose to spray unexpectedly.As a result, the patient, staff, and room were contaminated.The patient was cleaned, and the site received a replacement dose.The patient later returned the same day to receive the replacement dose.The root cause of this issue was that the syringe that was missing the inner portion of the male slip tip.This may have broken off in the luer cap, or have been missing during.Dispensing." item# 309632 lot# 5063045.
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 since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number 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: 22716301
• Report Number: 1213809-2025-00522
• Device Sequence Number: 21228331
• Product Code: FMF
• UDI-Device Identifier: 00382903096329
• UDI-Public: (01)00382903096329(17)300228(10)5063045
• 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): 08/22/2025

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: 5063045
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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