MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

Catalog Number	309703
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
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 5ml ll tip bulk convenience pak leakage it was reported by customer that the several syringes in this batch leak at the plunger.They are not airtight and are therefore no longer sterile.Verbatim: rcc received a complaint via email.Email(s) attached.Cat# of product being complained: bd309703 description of product: syringe tray 5ml ll st sp=pk 25ea/pk 12pk/ca lot or s/n(b)(6) complaint category: leaking reportable: no incident date: (b)(6) 1980 details of complaint (reported issue): several syringes in this batch leaked at the plunger.Additional information will be sent via separate email.Please note: incident date unknown.Several syringes in this batch leak at the plunger; they are not airtight and are therefore no longer sterile.Complaint noticed: during / after use problem frequency: 1st time customer exposure: patient injury: no qty affected: 1 pk samples available? no is customer requesting an rga? no customer response on 11-dec-2025.1.Please confirm if the piston is damaged or improperly fitted? no to my visual analysis 2.Was the leak caused by damage to the piston? no to my visual analysis if we look closely at the image, we see liquid in the piston.I have in my possession 4 copies of the concerned syringes (defective).
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 4 physical sample and 1 photo submitted for evaluation.The reported issue of leakage past stopper was not confirmed upon inspection of the samples.Analysis of the sample showed that no defects were observed in the photo nor the physical samples.All physical samples were leak tested an found to have no leakage observed.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the sample.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.

• Brand Name: BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23828735
• Report Number: 9610847-2025-00463
• Device Sequence Number: 13000562
• Product Code: FMF
• UDI-Device Identifier: 30382903097037
• UDI-Public: (01)30382903097037(10)5218659
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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: 309703
• Device Lot Number: 5218659
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown