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

Catalog Number	309659
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	07/23/2024
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 #: 309659.Batch#: 4080570.It was reported that the bd luer-lok had foreign matter.The following information was provided by the initial reporter: verbatim: complaint received via email(s) attached."i was preparing medications for the first cataract patient of the day, i pulled out a 1ml slip tip syringe and noticed the package was dirty.Upon further inspection the interior of the package was also dirty.Package was never opened." additional information provided: are you able to provide the address of the facility for us to ship the return label? 9000 w sura ln, greenfield wi 53228 (local representative informed me he was picking up the sample).Did you notice any unusual sounds or shifting inside the box when handling it? no can you describe any damage found to items inside the box? no damage within the box, single syringe had dirt within packaging.Can you describe external condition of the box upon receipt, any signs of mishandling/opened seals? box had no damage.Any picture of this complaint? yes, please see below.
Additional Manufacturer Narrative
(b)(4).- supplemental mdr - foreign matter.One sample was provided to our quality team for investigation.Through visual inspection, it was observed that the interior of the package had an unknown brownish discoloration.Fourier transform infrared spectroscopy (ftir) analysis was performed, and most likely match with cellulose material.The condition observed is non-conforming per product specification.Potential root cause for the foreign matter non-fluid path internal to package defect is associated with the packaging process.This condition is occurring below their expected frequency, so no corrective action is required at this time.Furthermore, a device history record review was completed for provided lot number 4080570.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
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: 20078916
• Report Number: 1213809-2024-00585
• Device Sequence Number: 7663886
• Product Code: FMF
• UDI-Device Identifier: 30382903096597
• UDI-Public: (01)30382903096597(11)240320(17)290228(10)4080570
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 01/02/2025

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: 309659
• Device Lot Number: 4080570
• 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: 08/06/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown