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	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Date of Event	01/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd blunt filter nrfit was involved with a reaction.The following information was provided by the initial reporter: "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.The above mentioned customer is participating in the mds-21nrfit001 study.The patient performed a spinal anesthesia with the following nrfit devices on (b)(6) 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 ¿ 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.
Additional Manufacturer Narrative
Pr 9584511 follow up report for corrections.This complaint was found to be a duplicate after the mdr was submitted, please refer to pr 9584592.The manufacturing plant was incorrect in the initial mdr.The manufacturing plant should be becton dickinson - franklin lakes, nj / 07417.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.H3 other text : see narrative below.
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: 18704492
• Report Number: 9614033-2024-00013
• Device Sequence Number: 15302734
• 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: 01/22/2024
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 02/14/2024
• 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