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

Catalog Number	405164
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Today dexco notifies that in the (b)(6) clinic there is a dissatisfaction on the part of the group of anesthesiologists of the institution regarding the use of the bd spinal probe, for which they are returning the order awarded by bionexo.The main cause for concern is the leakage of medication between the thread of the spinal probe and the syringe (precision care) used to administer the medication during the procedures, and they also report that these needles, which were delivered by another distributor, arrived with a deformity in their primary packaging (curvature).
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.H3 other text: see h10 manufacture narrative.
Event or Problem Description
Additional information: has there been any harm to patients/healthcare professionals? a: no was there a need for medical and/or surgical intervention due to the incidence (imaging tests, surgery, drug administration, etc.)? (detail) a: no was there exposure of blood/chemotherapy to mucous membranes (eyes, nose and mouth) or skin? if yes, indicate whether the exposure was from the patient or the practitioner and what measures were taken.(detail) a: no for sample collection: please inform: how many units are available for collection? no samples.
Additional Manufacturer Narrative
Photos received for investigation.Through visual inspection, it is observed in the photos the tyvek with the product¿s information (gage, inches, lot and batch number and expiration date) and a smaller label placed on the top of the needle¿s blister.The needle is unused and unopened; sealed in its blister.No actual samples were received.No defect or issues observed.Physical samples are required to further analyze.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.

• Brand Name: NEEDLE SPINAL S/SU 26GA 3-1/2IN QUINCKE
• Common Device Name: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19287311
• Report Number: 2618282-2024-00037
• Device Sequence Number: 15363753
• Product Code: BSP
• UDI-Device Identifier: 30382904051649
• UDI-Public: (01)30382904051649
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2024

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: 2108321
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown