MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ SPINAL TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

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.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Investigation conclusion: part number and lot number is unknown; a lot history review could not be performed.Root cause description: no root cause can be determined as no samples were received.Rationale: capa is not required at this time.

Event Description

It was reported that the bupivacaine anesthesia in the unspecified bd¿ spinal tray was ineffective and the patient had to be treated with general anesthesia.The following information was provided by the initial reporter: "aspiration".Reported incident date? several dates since (b)(6) 2020 until last month.Please confirm which item in the spinal tray malfunctioned the spinal bupivacaine part/ref/item number? do not have it.Lot number? unable to get that, but they are some of the boxes sent in the last months qty of damaged product involved? i would say 4-5 instances where no block was obtained after a very uneventful spinal technique.How many times has this issue occurred? 4-5 times.Please confirm patient not harmed.No harm, but all required to convert to general anesthesia, no time to repeat spinal".

• Brand Name: UNSPECIFIED BD¿ SPINAL TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10727633
• MDR Text Key: 214619750
• Report Number: 2243072-2020-01724
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2020
• 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): Required Intervention