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
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.
Additional Manufacturer Narrative
Correction: cancel mdr- information captured in the mfr report # 3002682307-2024-00250.

• 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: 20799456
• Report Number: 3002682307-2024-00244
• Device Sequence Number: 6895280
• 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
• Report Date (Section B): 12/20/2024

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: Health Professional
• Device Catalogue Number: 305895
• Device Lot Number: 2405002
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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