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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
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 leaked past stopper it was reported by the customer that syringes that leak from the plunger, meaning that the syringes are not leak-proof and are therefore no longer sterile.Verbatim: complaint category: leaking.Reportable: no incident date: (b)(6) 2025.Details of complaint (reported issue): syringes that leak from the plunger, meaning that the syringes are not leak-proof and are therefore no longer sterile.Risk of contamination of medications and therefore infection for the patient.Monetary loss for the syringes that were discarded (cost of the syringe and the medication).Complaint noticed: during / after use problem frequency: a few times.Patient injury: no.Has health canada been informed? no.Qty affected: 25 ea samples.Available? no.Is customer requesting an rga?: no.
Additional Manufacturer Narrative
Investigation results: a device history record review was completed by our quality engineer team for provided material number 309703 and lot number 5218659.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect, and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.
Event or Problem Description
Additional information: it is indeed 33 syringes from a batch.

• 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: 23768634
• Report Number: 9610847-2025-00454
• Device Sequence Number: 13419718
• Product Code: FMF
• UDI-Device Identifier: 30382903097037
• UDI-Public: (01)30382903097037(17)300531(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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: 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: 11/27/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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