MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE SP S/SU 25GA 4-11/16IN WHITACRE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number 409442

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Device problem code: a0504 - leak / splash.Patient problem code: f26 ¿ no health consequences or impact.

Event Description

This mdr covers: 2) there is drug leakage at the junction of the syringe with the spinal needle.1) it does not have a guide needle to make the puncture, it is necessary to make the puncture with a syringe needle and passing the spinal needle through this guide needle is difficult.2) there is drug leakage at the junction of the syringe with the spinal needle.3) it lacks firmness even if the stylet is in place, which makes it difficult to pass through the tissues.4) the tab of the key/notch system is sometimes raised and does not fit well, affecting the fit of the stylet inside the needle, favoring the biopsy effect and allowing it to bend easily, sometimes making it necessary to use 2 needles, more punctures and more risk of headache, postponing it and costs.Impact on the patient: waste of medication.This takes several episodes, they changed the syringes and made a condensation before reporting.

Event Description

No additional information received.

Manufacturer Narrative

Investigation summary: one video received by our quality team for investigation.Through visual inspection of the video, a health care provider administrating a spinal anesthesia to a patient with a 25ga (blue) needle.During this process the syringe leaks through the upper part of the hub, therefore leakage is confirmed.In the video are no references of the catalog nor batch number of the needle being used.No other defects or issues observed.Physical samples or additional photos are required to further analyze.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Based on the quality team's investigation and without a batch number we are not able to identify a root cause related to our manufacturing process at this time.Bd devices are designed to be molded components compatible with iso594 dimensions.Therefore, is recommended to use syringes compatible with iso standards.Additionally, bd does not manufacture needles with introducer needles, this is an additional item to be added to the purchase order.

• Brand Name: NEEDLE SP S/SU 25GA 4-11/16IN WHITACRE
• Type of Device: 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 60061
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 17996598
• MDR Text Key: 326393007
• Report Number: 2618282-2023-00090
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 30382904094424
• UDI-Public: (01)30382904094424
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 409442
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1