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

Catalog Number	305895
Medical Device Problem Codes	Break (1069); Difficult to Open or Close (2921)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/31/2024
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 needle eclipse safety shield did not close and then broke.The following information was provided by the initial reporter: during surgery, the surgeon passed empty syringe to the nurse after use.The plastic safety cover hadn¿t closed properly and had failed to secure closed needle stick injury resulted as the needs remained exposed.After injury a second attempt to close was attempted and the cover detached from the needle completely.12 nov: unfortunately there is no physical sample or picture as it was a used sharp and initially i didn't know there had been a second incident.There was no patient harm although she did have to have a second blood sample taken.However there were 2 members of staff that had inoculation injuries.If you have any further questions please ask.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
A device history record review was completed for provided material number: 305895 and lot number: 2405002.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 of reported lot number were obtained from the manufacturing facility.The retained samples showed no signs of defect with their safety mechanisms and it was possible to activate the safety mechanisms by following the instructions for use.Based on the investigation results, an exact manufacturing related cause could not be determined for this reported incident.Every single lot produced is tested prior to final release for safety shield activation.The assembly process has a 100% inspection system for safety shield activation.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.
Additional Manufacturer Narrative
Correction: additional information added to b.Annex f code updated.
Event or Problem Description
Additional information received: 29 nov 2024.Were there any diagnostics performed as a result of the contaminated needle stick? blood tests for inoculation injury policy.If yes, what diagnostics were performed? blood born disease screening.Was any medical intervention required? no.If yes, please describe what treatment was provided.

• Brand Name: BD 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: 20694238
• Report Number: 3002682307-2024-00240
• Device Sequence Number: 6546999
• Product Code: FMI
• UDI-Device Identifier: 00382903058952
• UDI-Public: (01)00382903058952(11)240507(17)290430(10)2405002
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2025

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: 305895
• Device Lot Number: 2405002
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 01/16/2025; Not provided
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 01/21/2025; 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown