MAUDE Adverse Event Report: BECTON DICKINSON WHITACRE SET 25GA 3-1/2IN; NEEDLE, SPINAL, SHORT TERM

Catalog Number 405076

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 01/24/2024

Event Type  malfunction  

Event Description

Please help us by notifying us that 11010080 probe spinal pta.Pencil 25 pcs.Is leaking sent lots 2307018 / 2306021.

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.Two lot numbers were reported: batch 2307018, creation date: 2023-07-25, expiration date: 2028-06-30.Batch 2306021, creation date: 2023-06-21, expiration date: 2028-05-31.

Event Description

No additional information.

Manufacturer Narrative

Photo received for investigation.Through visual inspection, an image is received showing the part of the paper where the reference number and lot number (2307018) are referenced.This image confirms one of the lots involved in the claim, but not the defect or the other lot mentioned (2306021).No defects or issues observed.A device history review was performed for the reported lot 2307018, 2306021 no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Three retained samples from the same lot were evaluated, no defects or issues observed.Leakage test performed, no defects were observed.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification all critical dimensions are within specification and there is no damage on the product.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.

• Brand Name: WHITACRE SET 25GA 3-1/2IN
• Type of Device: NEEDLE, SPINAL, SHORT TERM
• 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: 18684618
• MDR Text Key: 335210543
• Report Number: 3003152976-2024-00069
• Device Sequence Number: 1
• Product Code: MIA
• UDI-Device Identifier: 00382904050764
• UDI-Public: (01)00382904050764
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K210978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 405076
• Device Lot Number: 2306021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1