MAUDE Adverse Event Report: BD CARIBE LTD. BD¿ QUINCKE 20 GAUGE 6 INCH LONG SPINAL NEEDLE

Catalog Number	405211
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that before use of the bd¿ quincke 20 gauge 6 inch long spinal needle, there was no label.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
No samples were received as evidence for the complaint.Evidence provided were photos.A review of the device history record was completed for lot # 8108627.This product was manufactured from 23apr2018 to 24apr2018 on tic machine 4 under catalog number 700006001 (needle spinal 6 in quincke) lot 8106995, (b)(4).The lot comprises a total of four manufacturing shifts.In process inspections were performed at shift start up on 16 samples and every 4 hours on 8 samples (2 samples per cavity) including cannula visual characteristics and functional inspections per product specification.Final inspections were found in compliance with requirements.Bd was able to confirm the customers indicated failure mode with the photo.The most probable cause of the missing label in the shelf carton is related to jams at capmatic machine.Preventative maintenance on the machine were conducted as per schedule.Review of instrument calibrations documented on the in process and final quality records were found within their calibration due date.Based on the nature of the semi-manual packaging process, a missing label can be possible.Bd juncos will continue monitoring the complaints regarding missing labels and notification of the incident was shared with the packing personnel as an awareness mechanism.
Event or Problem Description
It was reported that before use of the bd quincke 20 gauge 6 inch long spinal needle, there was no label.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD¿ QUINCKE 20 GAUGE 6 INCH LONG SPINAL NEEDLE
• Common Device Name: NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 7903625
• Report Number: 2618282-2018-00061
• Device Sequence Number: 19217255
• Product Code: BSP
• UDI-Device Identifier: 30382904052110
• UDI-Public: 30382904052110
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 405211
• Device Lot Number: 8108627
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other