MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 18X1IN BLUNT FILL; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305181
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
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.
Event or Problem Description
Materials: 305181 batch#: unknown.Verbatim: coring of stopper with introduction of foreign matter into the vial when using the blunt fill needle on a vial of solumedrol.Additional information here is information from the nursing staff, in which this occurred with 2 different nurses and only solu medrol: when i went up to look at it, the needle was a bd blunt fill needle ¿ filter 18g x 1 ½.I don¿t have any lot or expiration information for the needle.I recommended that her staff use a needle with a bevel instead of the blunt tip to see if that made a difference, but i received another message from shanna that the issue was still happening.
Event or Problem Description
No additional information received.
Additional Manufacturer Narrative
(b)(4) follow up it was reported there is coring of stopper with introduction of foreign matter into the vial when using the blunt fill needle on a vial of solumedrol.As a needle sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, two photos were received for evaluation by our quality team.The photos show a vial and its labeling.No other information could be obtained from the photos.Based on the investigation with the photo sample analysis the symptom reported by the customer could not be confirmed.Without the actual physical needle sample analysis, a probable root cause could not be offered.

• Brand Name: NEEDLE 18X1IN BLUNT FILL
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• 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: 21513681
• Report Number: 1911916-2025-00173
• Device Sequence Number: 19958654
• Product Code: GAA
• UDI-Device Identifier: 30382903051817
• UDI-Public: (01)30382903051817
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K941562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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: 305181
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown