MAUDE Adverse Event Report: TRAY SPN WHIT25G3.5 L/B-D/E; ANESTHESIA CONDUCTION KIT

Model Number 405673

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is hdq us franklin lakes.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.The customer's address is unknown.New jersey (nj), usa has been used as a default.Pma/510(k)#: enforcement discretion.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that tray spn whit25g3.5 l/b-d/e was not working.The following information was provided by the initial reporter: material no.: 405673 ,back no.: unknown (1387545 or 1370473).It was reported that the anesthesia in the trays are not working.

Manufacturer Narrative

H.6.Investigation summary: no samples that display the reported condition were available for investigation.A review of the internal manufacturing device records and for the reported lot numbers was performed and no recorded quality problems or rejections related to the reported incident were found.The component involved is provided by a supplier whom we have notified of this incident initiated an investigation request.While we did not have a physical sample, we routinely perform evaluations to ensure our manufacturing process does not impact the potency of the drug provided within the kit, results were reviewed and all results were found to be acceptable.Complaints received for this device and reported condition will continue to be tracked and trended for future occurrence.Failure could not be confirmed as a manufacturing related defect (investigation inconclusive).As a result, capa/sa determination = not required.H3 other text : see h.10.

Event Description

It was reported that tray spn whit25g3.5 l/b-d/e was not working.The following information was provided by the initial reporter: material no.: 405673 back no.: unknown (1387545 or 1370473.It was reported that the anesthesia in the trays are not working.

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 11586625
• MDR Text Key: 268726714
• Report Number: 2243072-2021-00897
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056735
• UDI-Public: 00382904056735
• Combination Product (y/n): N
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 405673
• Device Catalogue Number: 405673
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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