MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB; SYRINGE, ANTISTICK

Catalog Number	305269
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe integra 3ml ll w/ndl 25x5/8 rb needle pulled out of the hub.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached date of events approximate.Reported by 3 different nurses in 3 different events that instead of the needle retracting following injection as intended, the needles detached from the syringe and remained in the patient's skin and required the rn to manually remove the needle.Reference report: mw5158656, mw5158657.Additional information provided: please see responses below.1.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No injury or adverse event.Needles were able to be removed from skin.2.Can you please provide an exact date of event in format dd-mmm-yyyy? we do not have exact dates.3.Can you please provide the material and lot number associated with reported issue? lot 3314055, see picture below.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation one photo was provided to our quality team for investigation.The photo shows a packaging blister top web and on the side a syringe with a needle assembly assembled to it.The needle assembly has plastic shield.No other information could be obtained from the photo.A physical sample is required for further investigation and potential root cause determination.Furthermore, a device history record review was completed for provided lot number 3314055.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 SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB
• Common Device Name: SYRINGE, ANTISTICK
• 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: 20348723
• Report Number: 1213809-2024-00685
• Device Sequence Number: 20848579
• Product Code: MEG
• UDI-Device Identifier: 30382903052692
• UDI-Public: (01)30382903052692(11)231110(17)281031(10)3314055
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: 305269
• Device Lot Number: 3314055
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 12/12/2024
• 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