MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305787
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that syringe 3ml ll w/ndl eclipse 25x1 rb scale marking issue.It was reported by the customer that scale markings are not printed in a straight setting.Sample kit requested for canadian team.Verbatim: rcc received a complaint via phone.Pir attached.Ref: (b)(4).Lot: 1301551.Issue: scale markings are not printed in a straight setting.Sample kit requested for canadian team mckesson is distributor.
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
Material#: 305787 batch#: 1301551 it was reported by the customer that scale markings are not printed in a straight setting.Sample kit requested for canadian team verbatim: rcc received a complaint via phone.Pir attached.Ref: (b)(4).Lot: 1301551 issue: scale markings are not printed in a straight setting.Sample kit requested for canadian team mckesson is distributor.
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.
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document # (b)(4)) on march 7, 2025.This documentation is available in bd document management system (sap) as (b)(4).This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family: eclipse.Device failure: scale marking issue.
Event or Problem Description
No additional information.

• Brand Name: SYRINGE 3ML LL W/NDL ECLIPSE 25X1 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: 20827917
• Report Number: 2243072-2024-01186
• Device Sequence Number: 20989520
• Product Code: FMI
• UDI-Device Identifier: 00382903057870
• UDI-Public: (01)00382903057870(11)211028(17)261031(10)1301551
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 04/03/2025

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: 305787
• Device Lot Number: 1301551
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 12/13/2024; Not provided
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 12/16/2024; 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown