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

Catalog Number	309695
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe control 10ml ll had foreign matter.The following information was provided by the initial reporter: material#: 309695, lot#: 5121447.It was reported by customer that item is busted open inside the individual plastic bags.Rcc received a complaint via email.Injuries or adverse event: no.Item: 309695, quantity affected: 1 bx, serial/lot number: (b)(6), po: (b)(4).Are any samples available for return? yes.Reported issue: item is busted open inside the individual plastic bags.Shipping boxes are not damaged and it is only some of the syringes.Customer disposition request: credit.Customer response on (b)(6) 2025.This issue was discovered on (b)(6) 2025.As for how many were affected, maybe 5 but i was uncomfortable using anything from that box so i replaced all of them and sealed it shut.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation twenty-five samples and one photo of 10 ml control syringes (part number 309695) from batch 5121447 were received and evaluated.Twenty-one syringes were found acceptable with no defects observed.Four syringes exhibited black discoloration across the bottom web; two also had large holes in the web, one had an open seal greater than ¼ inch, and one remained sealed.The photo confirmed the presence of black discoloration on the affected packages.The condition observed is non-conforming per product specifications.The potential root cause of the packaging damage and foreign matter defects is associated with the packaging process.Interviews with production personnel, along with a review of technical and electrical records and the production database, revealed fluctuations in seal temperature, which may have contributed to the observed defects.Furthermore, a device history record review was completed for provided lot number 5121447.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• Brand Name: 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: 22475805
• Report Number: 1213809-2025-00462
• Device Sequence Number: 20956986
• Product Code: FMF
• UDI-Device Identifier: 00382903096954
• UDI-Public: (01)00382903096954(10)5121447
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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: 5121447
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown