MAUDE Adverse Event Report: BECTON DICKINSON BD SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305789
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 1ml ll w/ndl eclipse 27x1/2 rb leaked.It was reported by customer that clinicians are saying they are leaking.I do not have a sample to turn in.Rcc received a complaint via email.Clinicians are saying they are leaking.I do not have a sample to turn in.Item: 305789 quantity affected: 2 ea serial/lot number: n/a po: (b)(4).
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
No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Event or Problem Description
06-jan-2025: additional information received is as follows: per customer: ¿when we inject the botox it is fine, the issue is when we pull the syringe out of the skin it continues to inject the botox.This leads to botox being sprayed all over the patient and they continually leak the whole injection time.This just happened last week in channahon.The botox get all over their faced and in their hair.Also you cannot see how much you are giving the patient as they are very hard to read due to being so shiny and the light reflecting off of them¿ first incident happened in december, still occurring.Lot #: 4099717.

• Brand Name: BD SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21158587
• Report Number: 2243072-2024-01314
• Device Sequence Number: 7573288
• Product Code: FMI
• UDI-Device Identifier: 00382903057894
• UDI-Public: (01)00382903057894(11)240430(17)290331(10)4099717
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• 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): 01/21/2025

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: 305789
• Device Lot Number: 4099717
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown