MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 18X1-1/2 BLUNT FILL; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305180
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, needle 18x1-1/2 blunt fill, mold on the cap.The following information was provided by the initial reporter: case description: there's mold on the cap and around the syringe, it happened to many syringes already and in quite a bit of boxes, since they had to remove them from a lot of floors.Right now, it's been in just this lot and they informed medline, their distributor, but they asked them to contact bd directly.Product: bd blunt fill needle 18 g x 1-1/2 in.Ref: 305180 lot: 6086265.
Additional Manufacturer Narrative
B3.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.Device evaluation it was reported that mold was present on the cap and around the needle.As a physical sample was not returned, a comprehensive sample evaluation could not be conducted.To support the investigation, one photograph was received and evaluated by our quality team.The photograph depicts a packaging blister top web and a needle assembly.The plastic shield contains dark-colored specks that are consistent with embedded degraded resin.This type of condition typically originates at startup or occurs intermittently during the injection molding process, where degraded resin may dislodge and become incorporated into molded components.A device history record review was completed for material number 305180, lot 6086265.The review did not identify 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 applicable specification requirements.No similar events have been reported for this lot to date.Based on the investigation, including the evaluation of the photographic evidence, the condition reported by the customer has been confirmed.

• Brand Name: NEEDLE 18X1-1/2 BLUNT FILL
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• 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: 25392322
• Report Number: 1911916-2026-00261
• Device Sequence Number: 10719042
• Product Code: GAA
• UDI-Device Identifier: 00382903051809
• UDI-Public: (01)00382903051809(11)260330(17)310228(10)6086265
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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: Health Professional
• Device Catalogue Number: 305180
• Device Lot Number: 6086265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown