MAUDE Adverse Event Report: BD CARIBE LTD. NEEDLE SPINAL S/SU 26GA 3-1/2IN QUINCKE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number	405164
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported connection issues.Description: it was reported that during the procedure, it is evident that the needle does not fit correctly with the syringe, causing medication leaks, loss of content, and the inability to use the device safely, as shown in the attached video.
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.B3.The date received by manufacturer has been used for this field.
Additional Manufacturer Narrative
Additional information: details from customer added to b5.Date of event also updated.Investigation results: a video was received by our quality team for evaluation.In the video, a healthcare provider is inserting the needle (no introducer is being used) in the patient¿s back, it is observed that the healthcare provider administers medication and drops of medication run through the gloves of the healthcare provider.The reported incident could be verified.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, the potential root cause is attributed to handling-related issues, as the complaint verbatim states, ¿the needle does not fit correctly,¿ and video evidence shows the healthcare provider holding the device at the connection during use.Since bd devices are molded to iso 594-dimensional specifications, the use of syringes compliant with iso standards is recommended to reduce the risk of the reported failure mode.A physical sample would be needed to conduct a more thorough investigation.This incident has been added to our database of reported incidents.
Event or Problem Description
Additional information: could you tell us how many units have been affected? 3 units.Could you confirm the batch number of the sample? 4323628.Could you tell us the date of the incident in dd/mm/yyyy? 10/01/2026.

• Brand Name: NEEDLE SPINAL S/SU 26GA 3-1/2IN 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: 24345553
• Report Number: 2618282-2026-00030
• Device Sequence Number: 9912592
• Product Code: BSP
• UDI-Device Identifier: 00382904051648
• UDI-Public: (01)00382904051648(17)291031(10)4323628
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K210978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2026

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: 405164
• Device Lot Number: 4323628
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/31/2026; 06/01/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/09/2026; 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown