MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 21X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305165
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material #305165, lot #3347656.It was reported by customer that leak at the base plastic end of the needle.Verbatim: rcc received a complaint via email.As per account, i wanted to report a defect with item product number 308-305165 (21g 1in needle only).There was a significant leak at the base plastic end of the needle.Please send a replacement for this item and inform xxxx canada inc of defect.Additional information: the exact date the event occurred was 15 apr 2025.I do have the defective product in my position and am able to return it.You can ship the return label to (b)(6) or email it to me, and we can put it in an envelope with the label to ship out.There was no harm to the patient or caregiver.The defect was noticed while trying to reconstitute medication, and there was only saline drawn into the syringe at the time (so no loss of medication).Our nurse noticed the defect, bagged it for me, and used a new one to continue reconstitution.
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 a leak was reported at the base of the needle's plastic end.To support the investigation, one unpackaged sample was submitted for evaluation by our quality team.Upon visual inspection, a void was identified in the molding approximately 5/16" from the base of the needle hub.The sample was assembled with a syringe containing saline solution, and leakage through the molding void was confirmed.No additional defects or irregularities were observed.This condition is typically associated with imperfections in the stripping bushing.A device history record (dhr) review was conducted for material number 305165, lot 3347656.The review did not reveal any quality issues during the production of this lot that could have contributed to the reported condition.No related quality notifications were identified.All manufacturing processes and final inspections were performed in accordance with specification requirements.The sample will be shared with production associates to raise awareness.To date, no other similar incidents have been reported for this lot.Based on the investigation and analysis of the returned sample, the customer-reported issue has been confirmed.

• Brand Name: NEEDLE 21X1 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: 21909693
• Report Number: 1911916-2025-00309
• Device Sequence Number: 8729067
• Product Code: FMI
• UDI-Device Identifier: 30382903051657
• UDI-Public: (01)30382903051657(11)231213(17)290228(10)3347656
• 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): 05/09/2025

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: 305165
• Device Lot Number: 3347656
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown