MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 25X5/8 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305122
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material # 305122 batch # 4060100 issue: pt was recapping needle and had a needle stick when needle pierced through safety sheild.Pt harm picture is available was the needle contaminated with bodily fluids that were not your own? no it was not.Were there any diagnostics performed as a result of the soiled needle stick? if yes, what diagnostics were performed? no, no diagnostics were performed.Was any medical intervention required? if yes, please describe what treatment was provided.No, no medical intervention was required.
Additional Manufacturer Narrative
(b)(4).Follow up it was reported the needle pierced through safety shield during recapping.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a needle with the plastic shield assembled to a syringe.The tip of the needle is through the shield.No other information could be obtained from the photo.It could be possible the customer is not using the product as intended.This product should not be recapped after use.A device history record review was completed for provided material number 305122, lot 4060100.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.
Event or Problem Description
No additional information received.

• Brand Name: NEEDLE 25X5/8 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20757050
• Report Number: 1911916-2024-00831
• Device Sequence Number: 18283122
• Product Code: FMI
• UDI-Device Identifier: 30382903051220
• UDI-Public: (01)30382903051220(11)240229(17)290331(10)4060100
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• 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: Lay User/Patient
• Device Catalogue Number: 305122
• Device Lot Number: 4060100
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown