MAUDE Adverse Event Report: UNSPECIFIED BD¿ SPINAL TRAYS; ANESTHESIA KIT

Catalog Number UNKNOWN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Awareness during Anaesthesia (1707); Insufficient Information (4580)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.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.(b)(4).

Event Description

It was reported that unspecified bd¿ spinal trays are not setting up properly.The following information was provided by the initial reporter: material no.: unknown, batch no.: unknown.It was reported that the spinal trays are not setting up properly.Per response email: yes we have several kits now that have not worked on patients i sent a couple of the front part of the kits in quite a while never heard back on them and when i complained about it again they said you never received anything.I have complained a couple times about this.Per email: we have had several spinal kits now since i complained before that its not setting up as a spinal and they end up putting the patient to sleep.So can you tell me what is going on with the trays because i sent like 3 of them in with lot numbers and everything and i never heard back from you.

Manufacturer Narrative

H6: investigation summary no sample was returned for analysis.Consequently, the investigation was not able to further evaluate the reported failure mode through a complaint sample analysis.A device history review could not be completed as the batch number provided could not be confirmed to be a lot related to any product produced by the manufacturer.Without a sample, photograph or other manufacturer lot information the investigation was unable to confirm the failure mode nor identify a probable root cause.As the failure mode was unable to be confirmed nor a root cause able to be determined a corrective and/or preventive action could not be identified for this complaint.

Event Description

It was reported that unspecified bd¿ spinal trays are not setting up properly.The following information was provided by the initial reporter: material no.: unknown batch no.: unknown it was reported that the spinal trays are not setting up properly.Per response email: yes we have several kits now that have not worked on patients i sent a couple of the front part of the kits in quite a while never heard back on them and when i complained about it again they said you never received anything.I have complained a couple times about this.Per email: we have had several spinal kits now since i complained before that its not setting up as a spinal and they end up putting the patient to sleep.So can you tell me what is going on with the trays because i sent like 3 of them in with lot numbers and everything and i never heard back from you.

• Brand Name: UNSPECIFIED BD¿ SPINAL TRAYS
• Type of Device: ANESTHESIA KIT
• MDR Report Key: 10891686
• MDR Text Key: 217958990
• Report Number: 2243072-2020-01918
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2021
• 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
• Patient Outcome(s): Other