MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 23X1; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305762
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd needle eclipse 23x1 safety shield broke off the following information was provided by the initial reporter; it was reported by the customer that safety mechanism malfunctioning and detaches during use.Verbatim: safety mechanism malfunctioning and detaches during use.
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 at 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
Mat# 305762; batch# 1055845.It was reported by the customer that safety mechanism malfunctioning and detaches during use.Verbatim: safety mechanism malfunctioning and detaches during use.Add info received 1st customer response are you able to provide the incident date? incident occurred on (b)(6) but after i spoke with staff i was told that this has been an ongoing issue so i¿m unsure of how long it¿s been.Is sample available for evaluation? if yes, kindly provide the facility address for us to create a return label.No, the needle was discarded.If you are unable to send a sample, could you provide any photo/video of the reported issue? it happens at random so unable to provide.What is the patient outcome? are there any adverse events/serious injuries? thankfully, the patient and the nurse were not injured the needle detached after the needle was pulled out of the patients arm.Was there a delay of, or change in, the course of treatment due to the event? no.What type of procedure is being performed? administration of a vaccine.What was the medication/fluid in use at the time of the event? the influenza vaccine.

• Brand Name: BD NEEDLE ECLIPSE 23X1
• 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: 18069737
• Report Number: 2243072-2023-01991
• Device Sequence Number: 18058798
• Product Code: FMI
• UDI-Device Identifier: 30382903057628
• UDI-Public: (01)30382903057628
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/16/2024

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 305762
• Device Lot Number: 1055845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown