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

Model Number 405211

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2021

Event Type  malfunction  

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 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
• Type of Device: 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11269741
• MDR Text Key: 230022816
• Report Number: 2618282-2021-00006
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 30382904052110
• UDI-Public: 30382904052110
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Other
• Device Model Number: 405211
• Device Catalogue Number: 405211
• Device Lot Number: 0211609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1