MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NEEDLE 23GA 1-1/2IN BNS TW; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	304142
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd needle 23ga 1-1/2in bns tw had foreign matter.The following information was provided by the initial reporter: material # 304142 batch # 5050183.It was reported by customer that a complaint sample for cardinal health complaint number case- (b)(4).Verbatim: rcc received a complaint via email.Email(s) attached.We received a complaint sample for xxxxxx complaint number case- (b)(4).Please see the attached photos of the affected sample.If you require the sample to be returned for investigation, please provide a shipping label.Thank you, additional information: material number: 304142.Lot number: 5050183.Patient impact: no.Sample available: yes.Needle from back table pack had white substance on it before ever being uncapped.Needle defective in pack from manufacture.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported that a needle exhibited a white substance.To aid the investigation, one unpackaged sample and six photographs were received by the quality team.A visual inspection was performed and identified an epoxy drip over on the needle.The photographs corresponded to the returned sample.No additional defects or imperfections were observed.This condition could be induced if a jam occurred at the cannulator.A device history record review was completed for material number 304142, lot 5050183.The review did not reveal any quality issues during production that could have contributed to the reported condition, and no related quality notifications were identified.All processes and final inspections complied with specification requirements.Cannulator verification was performed the settings were correct, and product flow was acceptable.To date, no other similar events have been reported for this lot.Based on the investigation and analysis of the returned sample, the customers reported condition is confirmed.

• Brand Name: BD NEEDLE 23GA 1-1/2IN BNS TW
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• 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: 23969364
• Report Number: 1911916-2025-00830
• Device Sequence Number: 13432969
• Product Code: FMI
• UDI-Device Identifier: 00382903041428
• UDI-Public: (01)00382903041428(17)300228(10)5050183
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: Other
• Device Catalogue Number: 304142
• Device Lot Number: 5050183
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown