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

Catalog Number	305195
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 305195.Batch # 4060183.It was reported by customer that needle was in a sealed package, no lid and appears to have rust particulates on it.Verbatim: i wanted to pass along a needle we found in our iv room last night.This needle was in a sealed package, no lid and appears to have rust particulates on it.
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
No additional information received.Material # 305195; batch # 4060183.It was reported by customer that needle was in a sealed package, no lid and appears to have rust particulates on it.Verbatim: i wanted to pass along a needle we found in our iv room last night.This needle was in a sealed package, no lid and appears to have rust particulates on it.
Additional Manufacturer Narrative
Pr (b)(4) follow up.It was reported the needle was in a sealed package, had no shield and appears to have rust particulates on it.As a physical sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, three photos were provided for evaluation by our quality team.Two photos show packaging shelf boxes.The third photo shows a needle assembled to a syringe with the plastic shield removed and an opened packaging blister.The needle has a dark colored particle adhered to it that appears to be a particulate of dust.No other defects or imperfections were observed.A device history record review was completed for provided material number 305195, lot 4060183.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.Without the actual physical sample analysis, a probable root cause could not be offered.

• 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: 20129287
• Report Number: 1911916-2024-00642
• Device Sequence Number: 20698545
• Product Code: FMI
• UDI-Device Identifier: 30382903051954
• UDI-Public: (01)30382903051954(11)240229(17)290531(10)4060183
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: 305195
• Device Lot Number: 4060183
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 09/19/2024
• 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