MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 16X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305197
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
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 # 305197, lot # 4158696.Verbatim: rcc received a complaint via email.Email(s) attached.The pharmacy team here orders a bd needle and found that some needles have had this white powder coating and needle mis matched.1.Can you please provide an exact date of event in this format mm-dd-yyyy? december 31, 2024.2.Please share the material & lot number associated with reported issue ¿ bd precision glide needle 16g lot 4158696.3.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.None.4.Any physical sample available for investigation? if yes, please provide the address of the facility for us to ship the return label? yes ¿ (b)(6).5.As you mentioned 'needle mis matched', we observed from the picture that the needle was missing from the package.Could you please confirm if the missing needle is the issue you are reporting? one needle was missing, and 2 needles were found with a white substance on them.One was discarded, one is available for inspection.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation it was reported some needles have a white powder coating and some have the needle missing.To aid in the investigation, five hundred twenty-seven samples in sealed packaging blisters and one photo was received for evaluation by our quality team.A visual inspection was performed.One packaging blister has the plastic shield but is missing the needle assembly.Another packaging blister has a needle assembly with an epoxy drip over on the needle hub.The photo provided shows some of the samples received.These defects could occur during the assembly process.The epoxy drip over if there was a jam at the cannulator and the needle missing if the needle was not assembled to the plastic shield.A device history record review was completed for provided material number 305197, lots 4158696 and 4159416.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.To date, there have been no other similar events reported for these lots.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.
Event or Problem Description
No additional information received.

• Brand Name: NEEDLE 16X1 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: 21147674
• Report Number: 1911916-2025-00015
• Device Sequence Number: 9088656
• Product Code: FMI
• UDI-Device Identifier: 30382903051978
• UDI-Public: (01)30382903051978(11)240606(17)290630(10)4158696
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/20/2025

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: 305197
• Device Lot Number: 4158696
• 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: 12/30/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown