MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 18X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305195
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
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#: 305195 batch number#: 4040631 it was reported by customer that fm found on the end of the needle.White material.Rcc received a complaint via phone.Pir attached.Ref 305195 lot: 4040631 issue: fm found on the end of the needle.White material doe: (b)(6)2024 no pt harm found before injection sample is available sample return kit requested, please.
Event or Problem Description
No additional information received.Material#: 305195.Batch number#: 4040631.It was reported by customer that fm found on the end of the needle.White material rcc received a complaint via phone.Ref 305195.Lot: 4040631.Issue: fm found on the end of the needle.White material.Doe: (b)(6) 2024 and (b)(6) 2024.No pt harm found before injection.Sample is available.Sample return kit requested please.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported there was foreign matter on the end of the needle.To aid in the investigation, one sample in an opened packaging blister was received for evaluation by our quality team.A visual inspection was performed, and the needle has an epoxy drip over at the needle tip.No other defects or imperfections were observed.This defect could occur if there was a jam at the cannulator.A device history record review was completed for provided material number 305195, lot 4040631.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.The sample will be shown to associates for awareness.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

• Brand Name: NEEDLE 18X1 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: 20224143
• Report Number: 1911916-2024-00666
• Device Sequence Number: 12625142
• Product Code: FMI
• UDI-Device Identifier: 30382903051954
• UDI-Public: (01)30382903051954(11)240209(17)290228(10)4040631
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: 305195
• Device Lot Number: 4040631
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown