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

Catalog Number	309577
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Material# 309577 batch# 2318360 it was reported that the bd luer-lok needle hub hole/cracked/damaged.The following information was provided by the initial reporter: "while using syringe 309577 for injection, hub snapped off, all medication leaked out and consumer was bleeding." cat: 309577 lot: 2318360 date of event: may 27th.Additional information provided: 1.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Yes when the hub broke off and the syringe barrel went into my skin and caused a laceration which required several stitches.The expensive (b)(6) medication spilled out and could not be administered this caused injury as a schedule 2 substance was discharged and not administered.2.Any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? the sample is available 3.Please share the captured photo of the event if available.
Additional Manufacturer Narrative
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
Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.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.

• 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: 19554584
• Report Number: 1213809-2024-00379
• Device Sequence Number: 12444993
• Product Code: FMF
• UDI-Device Identifier: 30382903095774
• UDI-Public: (01)30382903095774(11)221114(17)271031(10)2318360
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 309577
• Device Lot Number: 2318360
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown