MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE SPINAL S/SU 27GA 3-1/2IN QUINCKE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number	405081
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
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.Additional batch reported: batch: 3100744.Batch creation date: 2023-06-13.Batch expiration date: 2028-09-30 h3 other text : see h10 manufacture narrative.
Event or Problem Description
D spinal needle 27g(cat no.405081) lot: 3100744 exp.: 3/31/2028 - found fluid leakage between joint bd spinal needle 27g (cat no.405081) lot 3286308 exp.9/30/2028 - found fluid leakage between joint.Stop using these lot no.Change lot no.To customer for trial.Additional information: no harm to patient or caregiver.3.The report incident noticed during use.4.Csf fluid leak out during change syringe.
Additional Manufacturer Narrative
Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore, a root cause could not be determined.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.Based on the teams investigation, bd devices are designed to be molded components compatible with iso (international organization for standardization) dimensions.Therefore, it is recommended to use syringes compatible with iso standards.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.

• Brand Name: NEEDLE SPINAL S/SU 27GA 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 IA
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19329751
• Report Number: 2618282-2024-00039
• Device Sequence Number: 15181085
• Product Code: BSP
• UDI-Device Identifier: 30382904050819
• UDI-Public: (01)30382904050819
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K091758
• 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): 06/11/2024

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: 405081
• Device Lot Number: 3286308
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/12/2024
• 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