MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 18X1-1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305196
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 305196, batch # 4212623, 4270137.It was reported by customer that they have white particles attached to the needles.Verbatim: we have found 2 lots of bd precision glide needles 18g x 1 ½ inch ref 305196 that have white particles in the packaging and attached to the needles.The lots are 4212623 and 4270137.They were received from xxx.Customer response on 16-apr-2025.Date first noticed: (b)(6) 2025 for both lots.Could you please specify which lot number have "white particles in the packaging and attached to the needles" lot 4212623 and lot 4270137.
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.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation.It was reported there are white particles in the packaging and attached to the needles.To aid in the investigation, nine samples and two photos were received for evaluation by our quality team.Eight samples came in sealed packaging blisters and one sample came with no packaging blister.A visual inspection was performed.All the samples have an epoxy drop over on the needle hub.The two photos provided show a needle assembly with an epoxy drip over.No other defects or imperfections were observed.This condition occurs if there is a jam at the cannulator inducing the epoxy drip over.A device history record review was completed for provided material number 305196, lots 4212623 and 4270137.The review did not reveal any detected quality issues during the production of these lots that could have contributed to the reported condition.There were no related quality notifications.All processes and final inspections complied with specification requirements.Based on the investigation with the returned sample analysis the symptom reported by the customer is confirmed.

• Brand Name: NEEDLE 18X1-1/2 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: 21873078
• Report Number: 1911916-2025-00290
• Device Sequence Number: 7865151
• Product Code: FMI
• UDI-Device Identifier: 30382903051961
• UDI-Public: (01)30382903051961(11)240926(17)291231(10)4270137
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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: 305196
• Device Lot Number: 4270137
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown