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

Catalog Number	305064
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	04/29/2024
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
Material: 305064, batch#: 3310892.It was reported that the bd luer-lok had foreign matter.The following information was provided by the initial reporter: "item is visibly dirty inside sterile package before being opened.".Verbatim: rcc received a complaint via email.Email(s) attached.Item is visibly dirty inside sterile package before being opened.Customer did not specify the quantity affected; unknown, sample available, supplier please send customer sample return instructions.Cat# of product being complained: bd305064.Description of product: needle blunt fill 18gx1.5in w/ll 10ml srng 100ea/bx 4bx/ca.Lot or s/n: (b)(6).
Additional Manufacturer Narrative
It was reported the unit is visibly dirty inside sterile package.As a sample was not returned, a thorough sample evaluation could not be performed.A physical sample is required for a more thorough evaluation and potential root cause determination.A device history record review was completed for provided material number 305604, lot 3310892.All visual inspection were performed per requirements, and there were no quality notifications related to the reported defect.Batch 3310892 was inspected, accepted based on meeting our inspection control plan and was subsequently approved for shipment.To date there have been no other similar events reported for this lot.Further action has not been determined necessary at this time.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.
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: 19375470
• Report Number: 1213809-2024-00311
• Device Sequence Number: 7678293
• Product Code: FMF
• UDI-Device Identifier: 30382903050643
• UDI-Public: (01)30382903050643(11)231106(17)281031(10)3310892
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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: Other
• Device Catalogue Number: 305064
• Device Lot Number: 3310892
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown