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

Catalog Number	305766
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd needle eclipse 18x1-1/2 rb safety mechanism failed it was reported by the customer that safety came off needle.Verbatim: safety came off needle.
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
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 broken cannula catch/cannula lock pin at the safety shield molding in-process inspection; fail hook id inspection on the eclipse hub molding in-process inspection; activation/locking force functional test, deactivation/unlocking forces functional test and eclipse safety shield inspection at the qa outgoing inspection; and visual inspection of damage pivot pin at the packaging in-process inspection.Actual root cause could not be determined as no sample were received for investigation.The complaint will be re-opened and re-investigated when sample is received.
Event or Problem Description
Material: 305766 batch#: 3330692 it was reported by the customer that safety came off needle.Verbatim: safety came off needle.

• 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 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: 19345193
• Report Number: 2243072-2024-00633
• Device Sequence Number: 7339747
• Product Code: FMI
• UDI-Device Identifier: 30382903057666
• UDI-Public: (01)30382903057666
• 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
• Report Date (Section B): 05/23/2024

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: Other
• Device Catalogue Number: 305766
• Device Lot Number: 3330692
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown