MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. LUER-LOK; SYRINGE

Catalog Number	305618
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
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 (b)(6) syringe 30ml ll tip conv pak had foreign matter it was reported by customer that growth/foreign material is on the top of plunger.Incident description: as per client, having this growth like material after filling.It shows cloudiness after filling.In one of the pictures, it's very clear the growth/foreign material is on the top of plunger.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation summary: bd nogales was not able to confirm the customer indicated failure mode of fm - particles, since no evidence (pictures or samples) were provided to perform a further investigation.It is important to mention that nogales only perform the packaging of the syringes, only visual inspection in line during the loading of the syringe inside the trays, nothing related to the manufacturing or assembly of the syringes.Ftir analysis is pending.Dhr (device history record) was reviewed and no qns (quality notifications) or other events were found related to the complaint stated by the customer.According to sampling plan applied for product performance; this lot was accepted.We will keep monitoring the manufacturing process in case any emerging trend is detected.With no actual sample analysis, a probable root cause could not be offered.

• Brand Name: LUER-LOK
• 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): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24178183
• Report Number: 9610847-2026-00025
• Device Sequence Number: 15842246
• Product Code: FMF
• UDI-Device Identifier: 00382903056187
• UDI-Public: (01)00382903056187(17)300331(10)5112150
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: 305618
• Device Lot Number: 5112150
• 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: 05/05/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown