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

Catalog Number	309695
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	06/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Materials#: 309695 batch#: 4094819 it was reported that the bd luer-lok had foreign matter.The following information was provided by the initial reporter: we purchase our syringes from our distributor xxxxxxx- (our dsm, and local rep are included as well) today we were brought a perfectly sealed and sterile 10ml control syringe, part # 309695- lot # 40948191 thankfully, it was discovered prior to a procedure.There is some residue or dried fluid of some type, on the finger loop are of the plunger, the package is still perfectly sealed.I am including pictures of the effected component.We would like to generate an official product complaint and would like to send in the product directly to becton dickson for evaluation.I am currently waiting on my online access to complete the complaint form.If you could please email me to form for now, i would appreciate it.As i said previously, i am also attaching our distributor dsm (designated service manager) , as well as our rep as an fyi and their records as well, but would like to send this directly to the quality review department at bd.Please send email the specific forms that need completed and shipping information, so that we can get this sent asap.To reiterate here is the information of the affected item: part # 309695 , bd 10ml sterile control syringe, lot # 40948191 x1 each xxxxxxx, and xxxxxx, we believe that this was shipped under po (b)(4).We will also continue to include you in communications surrounding this occurrence.All, please see the attached for the pictures of the effected product, again the packaging is completely sealed.
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Two samples and five photos of 10ml control syringes were received by bd.A quality engineer was able to examine the samples and photos from batch 4094819 regarding item 309695.One sample was received in a sealed package and one in an unsealed package with all applicable product information on the top webs.Both samples have a reddish-brown foreign matter on the thumb-grip, non-fluid path internal to the package.Two of the photos show a different portion of the top web of the package with applicable product information, one showing the material number and one showing the batch number.The other three images each show a different view of one syringe in a sealed package covered in the reddish-brown foreign matter as described above.Ftir analysis was performed, however the results were inconclusive.The condition observed is non-conforming per product specification.As a part of this investigation a molding engineer was consulted.Potential root cause for the foreign matter non-fluid path internal to package defect is associated with the molding process.The foreign matter is most likely grease on the conveyor belt.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.A device history record review was completed for provided lot number 4094819 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
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: 19582077
• Report Number: 1213809-2024-00398
• Device Sequence Number: 17940952
• Product Code: FMF
• UDI-Device Identifier: 30382903096955
• UDI-Public: (01)30382903096955(11)240403(17)290331(10)4094819
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 10/25/2024

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: 309695
• Device Lot Number: 4094819
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown