MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD NEEDLE ECLIPSE 21X1.25 CE; NEEDLES, HYPODERMIC

Catalog Number	305895
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Insufficient Information (4580)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd needle eclipse 21x1.25 ce safety shield broke.The following information was provided by the initial reporter: safety shield broken.
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.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305895 and lot number 2401002.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.To aid in the investigation of this issue, four (4) pictures samples were provided for evaluation by our quality team.The pictures show an eclipse needle attached to a syringe; however, the needle does not have the safety shield assembled.Another picture shows a loose safety shield, but no signs of damage to the shield are identified through the picture.Twenty (20) additional retained samples of the sample lot number were obtained from the manufacturing facility for review.All of the safety mechanisms could be correctly activated by following the instructions for use (ifus).Based on the provided feedback and picture samples, we understand that this incident may be related to a safety shield that was not well assembled.We would like to inform you that our assembly process has a system in place which inspects all safety shields for proper activation and rejects any defects identified.Every lot is tested for final safety shield activation prior to release and lot number 2401002 complied with specifications.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.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.
Event or Problem Description
Response on 8-july-2024: i was seeing a patient for an implant, during the procedure, i injected lidocaine (local anaesthetic) into the patients arm, as i went to apply the safety guard to the needle, the guard snapped off and the needle went into my finger (index finger on my left hand): details of needle used - lot 2401002 exp: 31.12.2028.The patient was not harmed as a result of this and no blood came into contact with the patient.I ensured that this hand was not in contact with the patient when the implant was inserted.

• Brand Name: BD NEEDLE ECLIPSE 21X1.25 CE
• 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: 19443256
• Report Number: 3002682307-2024-00129
• Device Sequence Number: 8612063
• Product Code: FMI
• UDI-Device Identifier: 00382903058952
• UDI-Public: (01)00382903058952
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2024

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: 2401002
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 06/01/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown