MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE; NEEDLE, SPINAL, SHORT TERM

Catalog Number	405079
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.In this mdr, bd franklin lakes, nj has been listed in sections d.3.And g.1.As the manufacturing site is unknown.
Event or Problem Description
It was reported by the customer that needle broken.Verbatim: the broken needle i brought to you was a bd needle, not a xxx needle.The doctor give it to me together with the xxx tray, and i thought it was a xxx needle.Additional information received on 18jun2025.1.Can you please provide the material number/ lot number of the product associated with reported issue? don¿t know the material or lot numbers.2.When was the needle broke? during or before use? needle broke during use inside patient.3.Did the reported issue have any impact on the patient or hcp? patient required surgery to remove broken needle from the spine.
Additional Manufacturer Narrative
Additional information: patient information added.Material/lot information added.Investigation results: a sample was received by our quality team for evaluation.It is observed that the portion of the needle is bent near breakage area; therefore, the reported incident could be verified.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation, potential root cause can be directed to handling practices.As is explained in the instructions for use (ifu), care should be taken to avoid needle damage.Repeated repositioning can increase the risk of needle breakage and is therefore not recommended.Bd manufactures spinal needles of 18ga (thicker) up to 27ga (thinner).Based on product intended use; thinner gages are recommended to be used with an introducer needle in which assists in the placement of spinal needles.
Event or Problem Description
No additional information.

• Brand Name: NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE
• Common Device Name: NEEDLE, SPINAL, SHORT TERM
• 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: 22289238
• Report Number: 2243072-2025-00769
• Device Sequence Number: 21056146
• Product Code: MIA
• UDI-Device Identifier: 00382904050795
• UDI-Public: (01)00382904050795(17)271130(10)2334008
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 405079
• Device Lot Number: 2334008
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White