MAUDE Adverse Event Report: BD CARIBE LTD. BD¿ SPINAL NEEDLE WITH QUINCKE BEVEL; NEEDLE, CONDUCTION, ANESTHETIC

Model Number	405081
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd¿ spinal needle with quincke bevel experienced leakage at the connection site.The following information was provided by the initial reporter: after the procedure block the patient's back with spinal 27g and continue the syringe to inject drug the patient.Found that the drug was dripping directly between the needle joint and the syringe (hub).
Additional Manufacturer Narrative
Initial reporter addr 1: (b)(6).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: 17-jan-2023.H6: investigation summary photo samples was provided to our quality team for investigation.The photos display the material information as reported, and the photos comply with the specification to color, however, we are not able to confirm the indicated failures therefore we cannot verify the reported issue.A device history review was performed for the reported lot 2129539 and no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Inspections were performed according to procedure and had satisfactory results, product met required specifications for release.Based on our investigation, we cannot identify a definitive root cause at this time.
Event or Problem Description
It was reported that the bd¿ spinal needle with quincke bevel experienced leakage at the connection site.The following information was provided by the initial reporter: after the procedure block the patient's back with spinal 27g and continue the syringe to inject drug the patient.Found that the drug was dripping directly between the needle joint and the syringe (hub).

• Brand Name: BD¿ SPINAL NEEDLE WITH QUINCKE BEVEL
• Common Device Name: NEEDLE, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15988362
• Report Number: 2618282-2022-00093
• Device Sequence Number: 12287927
• Product Code: BSP
• UDI-Device Identifier: 30382904050819
• UDI-Public: 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
• 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
• Report Date (Section B): 01/25/2023

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 Model Number: 405081
• Device Catalogue Number: 405081
• Device Lot Number: 2129359
• 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: 11/23/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• 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