MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 25X1-1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305127
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Material: 305127 batch: 4262992 it was reported by the customer that noticed a white residue directly on the needle.Verbatim: rcc received a complaint via email.Email(s) attached.I am contacting you to report an isolated quality concern regarding a bd precisionglide 25g x 1½ tw needle (ref 305127), lot number 4262992, with an expiry date of 20290831.A patient came to my pharmacy after using this needle, which had been dispensed by another pharmacy.The primary packaging was intact prior to use.During the injection, the patient experienced abnormal resistance, and afterward noticed a white residue directly on the needle.The needle was used before the issue was identified.No adverse effects have been reported, and the patient was reassured.A photo is attached to this email.
Additional Manufacturer Narrative
(b)(4) follow up a white residue was reported to be present directly on the needle.As the physical sample was not returned, a comprehensive evaluation could not be conducted.To support the investigation, two photographs were submitted for review by our quality team.The first image depicts the top web of the packaging blister along with the needle assembly and its plastic shield.The second image, a magnified view, shows the needle with a white foreign substance.However, no further information could be obtained from the photographs alone.A device history record (dhr) review was completed for material number 305127, lot 4262992.The review found no quality issues during the production of this lot that could be linked to the reported condition.Additionally, there were no associated quality notifications.All manufacturing processes and final inspections were performed in accordance with specification requirements.To date, no similar incidents have been reported for this lot.Based on the photographic evidence, the customer¿s reported observation is confirmed.However, due to the absence of a physical sample, it was not possible to determine a probable root cause.
Event or Problem Description
Kindly provide the date of event around (b)(6) 2025.

• Brand Name: NEEDLE 25X1-1/2 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: 22053998
• Report Number: 1911916-2025-00358
• Device Sequence Number: 14750621
• Product Code: FMI
• UDI-Device Identifier: 30382903051275
• UDI-Public: (01)30382903051275(11)240918(17)290831(10)4262992
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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: 305127
• Device Lot Number: 4262992
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown