MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SAFETYGLIDE; PISTON SYRINGE

Catalog Number	309623
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 1ml s/t w/ndl 27x1/2 rb contained foreign matter.Complaint via email.Recently, i noticed after injecting my medication he would hurt more and bleed slightly, which was unusual.I started looking at the syringes before i inject it and so far, i have had three with a little white pump on the needle.At first, i thought it may be an isolated incident, but once i hit three, i brought it to the pharmacy and they told me to contact you.My main concern is if material could break off and get into mine or someone else¿s blood screening if you need to contact me my direct phone number is x.
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.E.1.Address was not located, and il was used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: SAFETYGLIDE
• 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: 25009989
• Report Number: 1213809-2026-00222
• Device Sequence Number: 15791287
• Product Code: FMF
• UDI-Device Identifier: 00382903096237
• UDI-Public: (01)00382903096237
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/08/2026

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: 309623
• Device Lot Number: 5204367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown