MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD® NEEDLE 5/8 IN. SINGLE USE, STERILE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D.4.The reported lot# [8024418]was not found for the reported catalog# [305122 ].H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using the bd® needle 5/8 in.Single use, sterile a needle stick occured.The following was reported by the initial reporter: we recently had a needle stick that resulted in medical treatment.
Additional Manufacturer Narrative
H6: investigation summary: it was reported the needle caps are hard to remove, a needle stick injury resulting in medical treatment occurred.A device history record review was completed for provided material number 305122, lot 8024418.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.Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.
Event or Problem Description
It was reported that while using the bd® needle 5/8 in.Single use, sterile a needle stick occured.The following was reported by the initial reporter: we recently had a needle stick that resulted in medical treatment.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Following the submission of the initial mdr, it was determined that the reported event was not reportable to the fda as it is not likely to cause or contribute to serious injury or death and the product was expired.

• Brand Name: BD® NEEDLE 5/8 IN. SINGLE USE, STERILE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17620782
• Report Number: 1911916-2023-00609
• Device Sequence Number: 14973425
• Product Code: FMI
• UDI-Device Identifier: 00382903051229
• UDI-Public: 00382903051229
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 305122
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 08/29/2023; Not provided
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 09/14/2023; 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown