MAUDE Adverse Event Report: BD CARIBE LTD. BD® TUOHY EPIDURAL NEEDLE 17G, THIN WALL X 3 ½; ANESTHETIC CONDUCTION NEEDLE

Catalog Number	405092
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd® tuohy epidural needle 17g, thin wall x 3 ½ contained a 20g needle instead of 17g.The following information was provided by the initial reporter: 20g epidural needle in the kit instead of 17g.20g epidural catheter cannot fit.
Additional Manufacturer Narrative
E.1.Initial reporter additional phone # (b)(6).H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 24-jul-2023 h6: investigation summary seventeen samples and photos received by our quality team for investigation.In the first photo, 2 needles are observed separated from the shield.In the second photo 17 needles with yellow handle (20 gauge) are seen in a plastic bag.It¿s observed that the needles have yellow handle (20 gauge), and these are not packed in a single sealed blister nor identified with catalog number and batch number.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Product undergoes visual inspections prior to release, including verifying the proper product and quantity is within each package.All inspections for these lots were completed according to procedure, no annotations were noted related to the reported incident.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.Distribution center receives approved product in case cartons, the distribution center does not perform any repackaging or sales individual shelf cases, it distributes whole boxes.
Event or Problem Description
It was reported that the bd® tuohy epidural needle 17g, thin wall x 3 ½ contained a 20g needle instead of 17g.The following information was provided by the initial reporter: 20g epidural needle in the kit instead of 17g.20g epidural catheter cannot fit.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document # (b)(4)) on march 7, 2025.This documentation is available in bd document management system (sap) as (b)(4).This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family: epidural needles.Device failure: mixed product / lots.

• Brand Name: BD® TUOHY EPIDURAL NEEDLE 17G, THIN WALL X 3 ½
• Common Device Name: ANESTHETIC CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17358201
• Report Number: 2618282-2023-00059
• Device Sequence Number: 6912867
• Product Code: BSP
• UDI-Device Identifier: 30382904050925
• UDI-Public: (01)30382904050925(11)210712(17)260531(10)1144677
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K211085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2025

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
• Operator of Device: Other
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 405092
• Device Lot Number: 1144677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 09/08/2023; Not provided
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 09/24/2023; 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown