MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 25X5/8; SYRINGE

Catalog Number	305759
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current control, there is a luer taper inspection at the molding first piece inspection per mqa-014/ax and luer taper inspection at the eclipse hub in-process inspection per mfg-043/aa.Actual sample was not received for further investigation.Root cause could not be determined.The complaint will be re-opened and re-investigated when sample is received.
Event or Problem Description
It was reported that bd needle eclipse 25x5/8 syringe needle connectivity issue.It was reported by customer that after injection to patient, nurse removed needle from the patient.Nurse attempted to engage the safety cover, and the needle disconnected from the syringe causing it to fly and land on the top of the other hand resulting in a needle stick to nurse.Rcc received a complaint via email.After injection to patient, nurse removed needle from the patient.Nurse attempted to engage the safety cover, and the needle disconnected from the syringe causing it to fly and land on the top of the other hand resulting in a needle stick to nurse.

• Brand Name: BD NEEDLE ECLIPSE 25X5/8
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20928486
• Report Number: 2243072-2024-01224
• Device Sequence Number: 8286221
• Product Code: FMI
• UDI-Device Identifier: 00382903057597
• UDI-Public: (01)00382903057597(11)231106(17)281031(10)3310013
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

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: 305759
• Device Lot Number: 3310013
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown