MAUDE Adverse Event Report: BECTON DICKINSON BD SYRINGE 3ML LL ECLIPSE 23X1-1/2 RB TW

Catalog Number	303306
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 bd syringe 3ml ll eclipse 23x1-1/2 rb tw safety shield broke off it was reported by customer that the guard of the injection needle broken when it was to be applied after the injection.Rcc received a complaint via email.Product code: 303306 product description: syringe & needle 3cc 23g x 1.5in l/l rb tw bx/50 lot/serial #: (b)(6) expiry date: 2027-09-30.Problem information product concern ticket number: (b)(4) (date of incident: (b)(6)2024 concern description: the guard on an injection needle broke when it was to be applied after the injection.This device problem has occured 4 times over the last year with clinican user.
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
No additional information.

• Brand Name: BD SYRINGE 3ML LL ECLIPSE 23X1-1/2 RB TW
• Common Device Name: SYRINGE
• 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: 21323664
• Report Number: 2243072-2025-00057
• Device Sequence Number: 20812685
• Product Code: FMF
• UDI-Device Identifier: 00382903033065
• UDI-Public: (01)00382903033065(11)221025(17)270930(10)2289198
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161170
• 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): 02/12/2025

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: 303306
• Device Lot Number: 2289198
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown