MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO MDS-21NRFIT; NEEDLE

Catalog Number	MDS-21NRFIT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); Vomiting (2144)
Date of Event	01/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a reaction after spinal anesthesia using the bd blunt filter nrfit needle."the adverse event occurred after using the devices and spinal anesthesia.The adverse event is not related to the devices but possible related to the spinal anesthesia." the following information was provided by the initial reporter: customer is participating in the mds-21nrfit001 study.The patient performed a spinal anesthesia with the following nrfit devices on (b)(6) 2024.Bd nrfit spinal needle set: whitacre 25g x 103.2 mm + introducer 20g x 31.8 mm - catalogue number 400229 - lot number 2109031.Bd nrfit syringe: slip 5ml, catalogue number 400051, lot number 83149.Bd nrfit blunt filter catalogue number 400066, lot number 3045501.Nausea and vomiting occurred on (b)(6) 2024 and resolved on (b)(6) 2024.The adverse event treated with a medication:one time application of an antiemetic drug (dimenhydrinat).Relationship to bd nrfit spinal needle: not related.Relationship to bd nrfit syringe: not related.Relationship to bd nrfit introducer: not related.Relationship to bd nrfit blunt filter: not related.Relationship to procedure: possible.The adverse event occurred after using the devices and spinal anesthesia.The adverse event is not related to the devices but possibly related to the spinal anesthesia.This complaint has been reported because it has a possible relationship with the procedure.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Pr# (b)(4) follow up report for corrections.The manufacturing plant was incorrect in the initial mdr.The manufacturing plant should be becton dickinson - (b)(4).Event details have been updated: adverse event with no malfunction, device unrelated.Adverse event related to procedure only.Medical device brand name, medical device catalog #, and medical device lot # have been updated to reflect the nrfit anesthesia study.No product identified as cause for the adverse event.Event related to procedure only.Pma/510k has been updated to na.
Event or Problem Description
Adverse event with no malfunction, device unrelated.Adverse event related to procedure only.

• Brand Name: MDS-21NRFIT
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18655497
• Report Number: 9614033-2024-00009
• Device Sequence Number: 7317272
• Product Code: GAA
• UDI-Device Identifier: 00382904000660
• UDI-Public: (01)00382904000660
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: MDS-21NRFIT
• Device Lot Number: MDS-21NRFIT
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown