MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 18X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305766
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation codes added.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batches.Current control there is a visual inspection on hook point, damaged needle and needle point blunt at the in-process inspection per mfg-043/i.Actual root cause could not be determined as actual sample was not returned investigation.The complaint will be re-opened and re-investigated when sample is received.
Event or Problem Description
It was reported that bd needle eclipse 18x1-1/2 rb needle coring, it was reported by customer that coring of vial with bd eclipse needle.Verbatim: coring of vial with bd eclipse needle.
Event or Problem Description
No additional information.
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: needle coring.

• Brand Name: BD NEEDLE ECLIPSE 18X1-1/2 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; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20558973
• Report Number: 2243072-2024-01080
• Device Sequence Number: 3088497
• Product Code: FMI
• UDI-Device Identifier: 00382903057665
• UDI-Public: (01)00382903057665(11)240411(17)290331(10)4099713
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,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: 305766
• Device Lot Number: 4099713
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 11/05/2024; Not provided
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/05/2024; 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown