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

Catalog Number	302437
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd eclipse needle safety mechanism broke.The following information was provided by the initial reporter: we have new 18g pink needles on the ward , bd eclipse.Used mostly for drawing up antibiotics.It was noted over the weekend twice that when using the safety guard to re sheath after that the safety guard itself broke off.2 jul 2024.¿ has there been any patient impact (serious injury, medical intervention, change of treatment required)? no impact to patients.Both incidents occurred in the clinical room when drawing up antibiotics.There was no sharps injury to the staff member either but potential for same.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 302437 and lot number 2310006.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were unavailable for return, twenty (20) retained samples were obtained from the manufacturing facility for review.Through examination of the samples, no defects were identified with the safety mechanisms and it was possible to activate them following the instructions for use.Based on the investigation results, an exact cause could not be determined for this reported incident.Regarding the report of safety mechanisms broken, every lot is tested for safety shield activation before release.The assembly process has a system that inspects all product for proper opening and activation of the safety shield, rejecting any defects identified.If this issue were to reoccur, we would greatly appreciate the opportunity to review the affected sample.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 ECLIPSE NEEDLE
• 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: 19700766
• Report Number: 3002682307-2024-00146
• Device Sequence Number: 7776157
• Product Code: FMI
• UDI-Device Identifier: 00382903024377
• UDI-Public: (01)00382903024377
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: 2310006
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown