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

Catalog Number	309642
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd luer-lok syringe leaked.The following information was provided by the initial reporter: it was reported by customer that colin spicer reported to fresenius medical care that on 02/20/2024 the floor staff told him that there was blood leak from the 10ml syringes and that it has happened 3 times this last month.He stated that it seems to be a repeated issue with these syringes for some reason.Verbatim: rcc received a complaint via email.Email(s) attached.Fresenius customer complaint (b)(4).Customer: (b)(6) product: bd 10ml luer-lok syringe 21gx1in vendor part#: 309642 lot number: 3284426 facility: (b)(6): (b)(6) reported to fresenius medical care that on 02/20/2024 the floor staff told him that there was blood leak from the 10ml syringes and that it has happened 3 times this last month.He stated that it seems to be a repeated issue with these syringes for some reason.
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
No additional information.
Additional Manufacturer Narrative
One photo of a 10ml luer-lok sringe (p/n - 309642) was received for evaluation or confirmation of reported defect.The image shows one loose syringe with the provided 21x1" needle not attached and not present in the photo, and the syringe is attached to a connector and tube which is connected to a machine.There is an unknown red fluid inside the syringe, inside the attached tube and splattered on the nearby equipment.Unable to confirm incident reported based on photos attached.Unused physical samples are required to further analyze.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.

• 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: 19081590
• Report Number: 1213809-2024-00211
• Device Sequence Number: 18052598
• Product Code: FMF
• UDI-Device Identifier: 30382903096429
• UDI-Public: (01)30382903096429(11)231011(17)280930(10)3284426
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/04/2024

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: 309642
• Device Lot Number: 3284426
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown