MAUDE Adverse Event Report: BD CARIBE LTD. NEEDLE SPINAL S/SU 18GA 6IN QUINCKE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number	408360
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A black substance was observed on product that passed through the spinal needle.No patient harm.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: three photos and four physical samples were received by our quality team for evaluation.The images include the tyvek packaging with catalog number, batch number, and expiration date, as well as a tip of a needle; according to the voice of the customer, the material passed through the needle and withdrew in a dirty condition (foreign matter).The samples received were sealed and unused in their packaging blister.They were submitted to inspection for testing.The inspection was executed, and the samples comply with the expected characteristics, the reported failure was not observed in the needles.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation, a root cause could not be determined.This incident has been added to our database of reported incidents.

• Brand Name: NEEDLE SPINAL S/SU 18GA 6IN QUINCKE
• Common Device Name: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24322466
• Report Number: 2618282-2026-00029
• Device Sequence Number: 9674178
• Product Code: BSP
• UDI-Device Identifier: 00382904083601
• UDI-Public: (01)00382904083601(17)280131(10)3041717
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K210978
• 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): 04/24/2026

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: 408360
• Device Lot Number: 3041717
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown