MAUDE Adverse Event Report: BD CARIBE LTD. NEEDLE SPINAL S/SU 20GA 6IN QUINCKE; ANESTHESIA CONDUCTION NEEDLE

Model Number	405211
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: one photo was received by our quality team for evaluation.Case carton label for catalog 405211 was observed.Labels contain all the characteristic required by the graphic control drawing.No defect is observed and complaint could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: a root cause could not be determined due to the defect not being verified.Rationale: per (b)(4) the reported issue does not represent a single significant incident that would trigger a capa.Per complaint history check is the 1st complaint reported for the defect/condition on lot number provided.
Event or Problem Description
It was reported that needle spinal s/su 20ga 6in quincke was damaged.The following information was provided by the initial reporter: hidden damage.

• Brand Name: NEEDLE SPINAL S/SU 20GA 6IN QUINCKE
• Common Device Name: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 11269741
• Report Number: 2618282-2021-00006
• Device Sequence Number: 13773928
• Product Code: BSP
• UDI-Device Identifier: 30382904052110
• UDI-Public: 30382904052110
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2021

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: 07/31/2025
• Device Model Number: 405211
• Device Catalogue Number: 405211
• Device Lot Number: 0211609
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1