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	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, needle blunt fill tip 18 gauge x 1.5 inch, after aspirating the contrast, a black spot was noted in that contrast/syringe.Customer description: writer prepped the definity bottle/vial by putting it in the vialmix machine.After it was mixed, writer removed the top plastic cover, and then wiped the vials rubber cap.A 25 gauge needle (bd lot # rekx3139) was punctured through the rubber cap for venting.Then a 18 gauge bd blunt fill needle (lot# 4082888) was connected to the 10 mg syringe.Then that 18 g needle was punctured through the definity rubber cap to aspirate the contrast.After aspirating the contrast, a black spot was noted in that contrast/syringe.Writer looked closer, but it somehow it seemed to have vanished.The dimly lit room did not help either.The writer removed that needle/syringe containing the contrast from the definity vial/bottle, then drained a few drops out to have approx.Volume of 1.33cc of contrast in that syringe.Then writer punctured/inserted that needle/syringe through a rubber cap of a 10cc vial 0.9 saline to aspirate the saline solution to mix with contrast.While writer was aspirating the 0.9 nacl in the syringe and it was mixing with the contrast, writer noted that black spot again which upon closer look it appears to be a small piece of rubber.Writer stopped aspiring the saline and removed the needle/syringe off of the vial cap of the 0.9 saline.Writer showed the syringed to department's educator.The contrast filled needle/syringe then secured.External surface was wiped with kimtech pure disinfectant.Manufacturer code/model: 305180 serial or lot number: (b)(6) expiry date: 2029-06-30 number of devices: 1 there was no serious harm reported.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported that a black spot was observed in the syringe.To support the investigation, one sample with an opened blister package was returned and evaluated by the quality team.A visual inspection was conducted at 30x magnification, which did not identify any damage, defective grind, or hook related issues.The bevels and etching were found to be acceptable.A device history record review was performed for material number 305180, lot 4082888.This review did not identify any quality issues during the manufacturing of the lot that could have contributed to the reported condition.No related quality notifications were identified, and all manufacturing processes and final inspections were completed in accordance with applicable specifications.Additionally, no similar events have been reported for this lot to date.Based on the investigation and the analysis of the returned sample, the condition described by the customer could not be 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: 25320029
• Report Number: 1911916-2026-00248
• Device Sequence Number: 17466541
• Product Code: GAA
• UDI-Device Identifier: 00382903051809
• UDI-Public: (01)00382903051809(11)240322(17)290630(10)4082888
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K941562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2026

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: 4082888
• 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: 05/25/2026
• Supplement Date Received by Manufacturer: 06/07/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown