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

Catalog Number	309695
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Material#: 309695, batch#: unknown.It was reported that the bd luer-lok had label content missing.The following information was provided by the initial reporter: verbatim: there is no expiration date on the syringe, and the only year printed on the packaging is 2003.Additional information provided: 1.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No.2.Was there any leak? no.3.Can you please provide an exact date of event in format dd-mmm-yyyy? multiple dates.4.Can you please provide the lot number associated with reported issue? we do not have packaging anymore.5.Any sample or photo available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? no.
Additional Manufacturer Narrative
(b)(4).Supplemental mdr/correction/additional information - label content missing.Correction: following submission of initial mdr, the customer information was not correctly reported.Section e updated to reflect correct customer address.Additional information: the sample received in a sealed package is embossed with the batch 1005561 on the package, batch updated from unknown to 1005561 in section d evaluation: one sample and two photos were provided to our quality team for investigation.The sample received in a sealed package is embossed with the batch 1005561 on the package tab with the top web graphics stating revision 03.One photo shows the top web side of the package with all applicable product information, but missing the variable data, and the nest image shows the batch number embossed on the package tab as described above.Based on the batch number and the packaging graphics the syringe was manufactured in 2011.This batch was manufactured prior to the unique device identification (udi) requirements that mandated marking individual packaging with expiration date.This batch was manufactured correctly per product design at the time.The syringe from batch 1005561 has been expired since 2016.Bd does not make claims of the efficacy of expired product.It is not recommended that product from this batch be used.
Event or Problem Description
No additional information was provided.

• 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: 21384839
• Report Number: 1213809-2025-00097
• Device Sequence Number: 8461717
• Product Code: FMF
• UDI-Device Identifier: 30382903096955
• UDI-Public: (01)30382903096955
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/13/2025

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: 1005561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown