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

Catalog Number	MDS-21NRFIT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	02/09/2024
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
The above mentioned customer is participating in the mds-21nrfit001 study.The patient has collapsed seconds after the beginning of the study procedure (spinal anesthesia), drop in blood pressure and bradycardia.The adverse event resolved started on 09-feb-2024 and resolved on the same date.The patient explained previous collapse during prostate biopsy due to stress and fear.The spinal nrfit needle was not successfully placed due to the circulatory collapse of the patient.Action taken due to the adverse event: device removed.Relationship to bd nrfit spinal needle quincke set catalog number 400226, lot number 2103704: not related.Relationship to bd nrfit syringe slip 5ml catalog number 400051, lot number 3117599: not related.Relationship to bd nrfit introducer as part of the set catalog number 400226, lot number 2103704: not related.Relationship to bd nrfit blunt filter catalog number 400066, lot number 2327051: not related.Relationship to procedure: causal.
Additional Manufacturer Narrative
Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.
Event or Problem Description
No additional information received.

• Brand Name: MDS-21NRFIT
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18903080
• Report Number: 2243072-2024-00284
• Device Sequence Number: 18425884
• Product Code: GAA
• UDI-Device Identifier: 00382904000660
• UDI-Public: (01)00382904000660
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: NA
• 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): 04/23/2024

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: 11/30/2025
• Device Catalogue Number: MDS-21NRFIT
• Device Lot Number: 2327051
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• 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