MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK; PISTON SYRINGE

Catalog Number	300912
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
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 10 ml ll eurographics contained foreign matter.It was reported that for one of our lyophilized products, we have observed an increased occurrence of cellulose fibers in the reconstituted product, which we are currently investigating.As part of this investigation, we are retracing the steps involved in the reconstitution process.In this context, we would like to exclude potential sources of the fibers.This includes syringes used for reconstitution from bd, as the individual packaging is partially made of cellulose.Response required from for our investigation: is the presence of cellulose fibers on or within the materials prior to opening the individual packaging known or considered possible? are you aware of any (increased) occurrence of cellulose fibers associated with this material? thank you for your prompt response.First of all, i would like to clarify that the request i have submitted is not a complaint, but we are asking for your support for an internal investigation.As part of our internal investigation, possible causes of contamination by cellulose fibres (300-800 m in length) in one of our lyophilized products after reconstitution of the product are to be discussed.The syringes mentioned below were used to reconstitute the lyophilized product with water for injection.We have identified the outer packaging of the syringes as a potential cause as it is made of cellulose.I will gladly provide you with the requested information as far as available.The reconstitution with accumulation of cellulose fibers was carried out on (b)(6) 2026.No samples are available.The request refers to a technically sound assessment on your part as to whether you are aware of an accumulation for the material mentioned, or whether there is a possibility that cellulose fibers from the packaging may be introduced into the syringe before it is used.The syringes are used in an analytical environment and only come into contact with water for injection (no contact with blood or medication).The syringes have been used.The cellulose fibers were not detected in the syringe, but in a downstream analysis.
Additional Manufacturer Narrative
Investigation results: since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.A physical sample is required for a more thorough evaluation and potential root cause determination.We will continue monitoring the complaint trend for the product and symptom.This batch is considered in compliance with our product specification requirements.The complaint was not confirmed, and no capa evaluation was required.This complaint type will continue to be trended within the post-market surveillance process, and any determined escalation will be managed there.
Event or Problem Description
No additional information.

• Brand Name: BD LUER-LOK
• 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: 24632027
• Report Number: 1213809-2026-00129
• Device Sequence Number: 9014874
• Product Code: FMF
• UDI-Device Identifier: 00382903009121
• UDI-Public: (01)00382903009121
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: Other
• Device Catalogue Number: 300912
• Device Lot Number: 5112634
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2025
• 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