MAUDE Adverse Event Report: CAREFUSION, INC BD¿ SPINAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number 400866

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.Initial reporter email address: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the anesthesia failed to administer while using the bd¿ spinal anesthesia tray.This event occurred 6 times.There was no report of patient impact.The following information was provided by the initial reporter: they have had six failed attempts at administering due to the bupivacaine/dextrose/marcaine vial being degraded.These six attempts were made by three different anesthesiologists.

Manufacturer Narrative

The following fields have been updated with corrected and/or additional information: multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: d4.Medical device lot #: 0001424490, d4.Medical device expiration date: 07/13/2021, h4.Device manufacture date: 06/30/2022.D4.Medical device lot #: 0001426415, d4.Medical device expiration date: 07/28/2021, h4.Device manufacture date: 06/30/2022.

Event Description

It was reported that the anesthesia failed to administer while using the bd¿ spinal anesthesia tray.This event occurred 6 times.There was no report of patient impact.The following information was provided by the initial reporter: they have had six failed attempts at administering due to the bupivacaine/dextrose/marcaine vial being degraded.These six attempts were made by three different anesthesiologists.

Event Description

It was reported that the anesthesia failed to administer while using the bd¿ spinal anesthesia tray.This event occurred 6 times.There was no report of patient impact.The following information was provided by the initial reporter: they have had six failed attempts at administering due to the bupivacaine/dextrose/marcaine vial being degraded.These six attempts were made by three different anesthesiologists.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes.D9: returned to manufacturer on: 03-mar-2020.H6: investigation summary three ampules sample were provided to our quality team for evaluation.The returned samples contained a clear and colorless solution free from visible particles.Ampules appeared clear with no discernible haze or particulate matter; therefore, the reported failure could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers 0001426415 and 0001424490 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Based on the available information we are not able to identify a root cause at this time.H3 other text : see h10.

Manufacturer Narrative

Correction: the following fields have been corrected.B5: describe event or problem: it was reported that the anesthesia failed to administer while using the bd¿ spinal anesthesia tray.This event occurred 11 times.There was no report of patient impact.The following information was provided by the initial reporter: they have had five failed attempts at administering due to the bupivacaine/dextrose/marcaine vial being degraded from an lot 400866.They have had six failed attempts at administering due to the bupivacaine/dextrose/marcaine vial being degraded from an unknown lot.These attempts were made by three different anesthesiologists.H1: type of reportable events serious injury.

Event Description

It was reported that the anesthesia failed to administer while using the bd¿ spinal anesthesia tray.This event occurred 11 times.There was no report of patient impact.The following information was provided by the initial reporter: they have had five failed attempts at administering due to the bupivacaine/dextrose/marcaine vial being degraded from an lot 400866.They have had six failed attempts at administering due to the bupivacaine/dextrose/marcaine vial being degraded from an unknown lot.These attempts were made by three different anesthesiologists.

Event Description

It was reported that the anesthesia failed to administer while using the bd¿ spinal anesthesia tray.This event occurred 11 times.There was no report of patient impact.The following information was provided by the initial reporter: they have had five failed attempts at administering due to the bupivacaine/dextrose/marcaine vial being degraded from an lot 400866.They have had six failed attempts at administering due to the bupivacaine/dextrose/marcaine vial being degraded from an unknown lot.These attempts were made by three different anesthesiologists.

Manufacturer Narrative

The following fields were corrected: b.1adverse type: the reported issue is both an adverse event and product problem.B.2 event attributed to: required intervention.C.1.Name, manufacturer/compounder, strength: bupivacaine hcl (0.75%) with dextrose (8.25%), 2 ml (marcaine).G5.Is combination product? yes.H5: imdrf annex f grid: f12.

Manufacturer Narrative

B.1 adverse type: product problem; b.2 event attributed: na; h1: type of reportable events: malfunction; h5: imdrf annex f grid: f24.No information was received on medical intervention or patient impact.This supplemental is to correct the event back to malfunction as no serious injury was reported.H3 other text : see h10.

Event Description

It was reported that the anesthesia failed to administer while using the bd¿ spinal anesthesia tray.This event occurred 6 times.There was no report of patient impact.The following information was provided by the initial reporter: they have had six failed attempts at administering due to the bupivacaine/dextrose/marcaine vial being degraded.These six attempts were made by three different anesthesiologists.

• Brand Name: BD¿ SPINAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13334653
• MDR Text Key: 285699716
• Report Number: 1625685-2022-00021
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/05/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 400866
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 01/24/2022
• Supplement Dates Manufacturer Received: 01/05/2022; 04/13/2022; 02/03/2023; 02/03/2023; 06/05/2023
• Supplement Dates FDA Received: 01/28/2022; 04/21/2022; 02/04/2023; 02/17/2023; 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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