MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number	405180
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Material # 405180 lot # 4134383, 4015086 verbatim: rcc received a complaint via phone.Pir attached.Caller states they have product code 405180 with lot#4134383 and 4015086.Caller states that they are labeled differently by 1.1mm.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Three photos were provided by the customer as evidence for this investigation.It is observed two (2) shelf cartons of 25ga needle (one (1) with blue label and one (1) with orange label).In the third photo is seen the two (2) shelf carton on the side showing part of the label with the catalog number and the needle measurements (in the blue label the measurements are in metric size (whole numbers) and the orange label are in metric size (decimal numbers).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.In may 2024 was implemented to all labeling levels a unit conversion from inch to mm in needle length configurations (decimal numbers).This change did not impact the product because the length of the needle is the same but, reflected in decimal numbers.Also, in may 2024 a resin color change in the handle of the stylet was implemented to comply with iso standards.

• Brand Name: NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE
• Common Device Name: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19923518
• Report Number: 2618282-2024-00097
• Device Sequence Number: 12790529
• Product Code: BSP
• UDI-Device Identifier: 00382904051808
• UDI-Public: (01)00382904051808(11)240221(17)281231(10)4015086
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: Health Professional
• Device Catalogue Number: 405180
• Device Lot Number: 4015086
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown