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

Catalog Number	305195
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2024
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#: 4031647.It was reported by customer that this weekend our staff discovered a black spot/fleck(s) on the inside tip of the bevel of some bd 18ga precision glide needles.One of our technicians rubbed off the material using the needle cover (see picture to the right).Also attached are two pictures showing the inside bevel of the needle where the black mark is.These were all from lot# 4031647 and we have them sequestered currently.Verbatim: complaint received via email(s) attached.Rcc received a complaint via email.Email(s) attached.This weekend our staff discovered a black spot/fleck(s) on the inside tip of the bevel of some bd 18ga precisionglide needles.One of our technicians rubbed off the material using the needle cover (see picture to the right).Also attached are two pictures showing the inside bevel of the needle where the black mark is.These were all from lot# 4031647 and we have them sequestered currently.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation.It was reported there was a black spot on the inside tip of the bevel.To aid in the investigation, six samples were received for evaluation by our quality team.Two samples came in sealed packaging blisters and four samples came with opened packaging blisters.A visual inspection was performed.First, with 10x magnification, and then with 30x magnification.Four of the samples have no defects or imperfections.Two of the samples have a dark colored particle at the needle tip.It is about 1/32" in size and is similar to the equipment lubricant.No other defects or imperfections were observed.This defect could occur if, after maintenance or repair of the cannulator, residues of equipment lubricant were not removed.A device history record review was completed for provided material number: 305195, lot: 4031647.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 samples will be shown to associates for awareness.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.
Event or Problem Description
Additional information received.Please confirm whether there was any patient impact.Not that we are aware of any adverse event or serious injury reported to patient or healthcare professional? no there was not.Material#: 305195, batch#: 4031647.It was reported by customer that this weekend our staff discovered a black spot/fleck(s) on the inside tip of the bevel of some bd 18ga precision glide needles.One of our technicians rubbed off the material using the needle cover (see picture to the right).Also attached are two pictures showing the inside bevel of the needle where the black mark is.These were all from lot#: 4031647 and we have them sequestered currently.Complaint received via email(s).Rcc received a complaint via email.This weekend our staff discovered a black spot/fleck(s) on the inside tip of the bevel of some bd 18ga precisionglide needles.One of our technicians rubbed off the material using the needle cover (see picture to the right).Also attached are two pictures showing the inside bevel of the needle where the black mark is.These were all from lot#: 4031647 and we have them sequestered currently.

• 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: 19968197
• Report Number: 1911916-2024-00585
• Device Sequence Number: 8785072
• Product Code: FMI
• UDI-Device Identifier: 30382903051954
• UDI-Public: (01)30382903051954
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/28/2024

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: 4031647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown