MAUDE Adverse Event Report: BECTON DICKINSON MDS-21NRFIT; ANESTHESIA CONDUCTION KIT

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 01/22/2024

Event Type  Injury  

Event Description

The above mentioned customer is participating in the mds-21nrfit001 study.The patient performed a spinal anesthesia with the following nrfit devices on 22-january 2024.However, the anesthetic medication was not successfully injected through the bd syringe as patient collapsed during the punction attempt and then wanted a general anesthesia.¿ bd syringe nrfit lot number: 83149, ¿ ancillary device used (catalogue number/type/size): ¿ 400066/bd blunt filter nrfit needle/18g x 1 1/2(1.2 mm x 40 mm) ¿ bd blunt fill or blunt filter nrfit needle lot number: 3045501 ¿ bd syringe nrfit (catalog number/type/size): 400051/syringe nrfit slip/5ml ¿ bd spinal nrfit needle set lot number : 2109032 ¿ an adverse event "hypotension with bradycardia" was reported on 22nd of jan2024 and resolved on the same day.The adverse event was treated with akrinor 100mg.And patient was laid down.¿ device was removed and subject was given general anesthesia.¿ relationship to spinal needle: not related ¿ relationship to syringe: not related ¿ relationship to introducer: not related ¿ relationship to ancillary devices: not related ¿ relationship to procedure: possible the adverse event occurred after using the device.The event is possibly related to procedure.This complaint has been reported because it has a possible relationship with the procedure.

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Manufacturer Narrative

No photos or physical samples that display the reported condition were available for investigation.A device history record review was completed by our quality engineer team for provided material number 400230 and lot number 2109032.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.

Event Description

No additional info.

• Brand Name: MDS-21NRFIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18702625
• MDR Text Key: 335355337
• Report Number: 3003152976-2024-00077
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904002305
• UDI-Public: (01)00382904002305
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K192538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention