MAUDE Adverse Event Report: BD SUZHOU (MDS) BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK

Catalog Number	309702
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
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
It was reported that bd syringe 3ml ll tip bulk convenience pak had foreign matter material #309702 batch #5127598.It was reported by customer that found two 3ml syringes with what was identified as silicone on them.Rcc received a complaint via email.Dmr # po #: defect material description: syringe tray, 3ml bd 25pk (ref.309702) lot number: 5127598 item code: 309702.Defective quantities: 2.Defect description: found two 3ml syringes with what was identified as silicone on them.Observed date: (b)(6) 2026.Observed during which process stage: compounding ir/ dmi number if launched: sample availability for supplier to investigate: no is defective evidence (i.E.Pictures; test results etc.) available? yes, is patient impacted? no if defect has been reported to third party? no if the defect report from quva customer? no is there a trend observed? no supplier action awareness/ attention.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 2 photos submitted for evaluation.The reported issue of foreign matter was not confirmed upon inspection of the photos.Analysis of the sample showed that each photo shows one loose syringe filled with an unknown clear fluid with an unknown grey particulate on the barrel non-fluid path.Bd cannot confirm the cause of the failure since no sample was returned for evaluation.Examination of the actual product involved may provide clarification as to the cause of the reported failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24178186
• Report Number: 9610847-2026-00028
• Device Sequence Number: 9557850
• Product Code: FMF
• UDI-Device Identifier: 30382903097020
• UDI-Public: (01)30382903097020(17)300331(10)5127598
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/03/2026

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: Health Professional
• Device Catalogue Number: 309702
• Device Lot Number: 5127598
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown