MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD NEEDLE ECLIPSE; NEEDLES, HYPODERMIC

Catalog Number	302437
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.B3.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that bd needle eclipse safety shield broke off.The following information was provided by the initial reporter, translated from french to english: i am writing to inform you that we are experiencing difficulties with the bd eclipse safety canula (302437).We have recorded 4 broken canulas in 3 months.This represents a real danger and risk of puncture for our technicians.Additional information: could you please provide us with the dates of the incidents that have occurred in the last 3 months and confirm when and how many people have been affected.5 people (last incident on 27/09/24) could you provide us with the batch numbers of the defective product? not available as batches are not traced internally.We would like you to confirm whether samples are available for investigation.If so, please specify whether the samples are: the canulas have been discarded.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
To aid in the investigation of this issue, one (1) picture sample was provided for evaluation by our quality team.Through examination of the picture, an eclipse needle was observed with the safety shield disengaged.However, without the physical sample, we are not able to identify an exact cause for this issue.As a lot number was unavailable for this event, a review of the production history records could not be completed and retained samples of the same lot could not be obtained for further testing.If this event were to reoccur, we would greatly appreciate the opportunity to review the affected sample.We would like to inform you that every single lot produced is tested for final safety shield activation prior to release.Our assembly process has a system in place which inspects all needles for proper opening and activating of the safety shield, with any defective product rejected.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• Brand Name: BD NEEDLE ECLIPSE
• Common Device Name: NEEDLES, HYPODERMIC
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20538216
• Report Number: 3002682307-2024-00220
• Device Sequence Number: 18197589
• Product Code: FMI
• UDI-Device Identifier: 00382903024377
• UDI-Public: (01)00382903024377
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: 302437
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown