MAUDE Adverse Event Report: BD CARIBE LTD. BD¿ LONG LENGTH SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE

Model Number	408360
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd¿ long length spinal needle experienced inconsistent labelling information.The following information was provided by the initial reporter: differing expiry date stated on the certificate of compliance and the packaging.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary no samples or photos were received from the customer for this investigation.Based on the investigation bd juncos was able to confirm the customer¿s failure mode.However, the product is properly labeled with the correct date.This complaint is systematic, the most probable cause is operator error.A review of the device history record was performed, and no quality issues were found during production.
Event or Problem Description
It was reported that the bd¿ long length spinal needle experienced inconsistent labelling information.The following information was provided by the initial reporter: differing expiry date stated on the certificate of compliance and the packaging.

• Brand Name: BD¿ LONG LENGTH SPINAL NEEDLE
• Common Device Name: ANESTHESIA CONDUCTION NEEDLE
• 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: 15277750
• Report Number: 2618282-2022-00048
• Device Sequence Number: 6485585
• Product Code: BSP
• UDI-Device Identifier: 30382904083602
• UDI-Public: 30382904083602
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K210978
• 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): 09/01/2022

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 Expiration Date: 05/31/2026
• Device Model Number: 408360
• Device Catalogue Number: 408360
• Device Lot Number: 1182339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• 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