MAUDE Adverse Event Report: CAREFUSION, INC BD¿ SPINAL TRAY

Catalog Number 405733

Device Problems Component Missing (2306); Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that bd¿ spinal tray was missing label information.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: no samples were provided for evaluation.However, the bupivacaine and marcaine drug components were intentionally removed per an internal project due to supply chain disruption.Based on the complaint investigation results, no probable root cause associated with the manufacturing process was identified.Since no probable root cause was identified, no corrective and/or preventive actions were identified for this complaint.This complaint will be added to the complaint management system and will be tracked & trended for future occurrences through the quality data analysis process.A review of the device history record shows that all inspection results passed per the dhr process and no anomalies were noticed during production.The review also noted that lot 0001253521 was manufactured per a project without the bupivacaine and marcaine drug components due to supply chain disruptions with the vendor.

Event Description

It was reported that bd¿ spinal tray was missing label information.No serious injury or medical intervention was reported.

• Brand Name: BD¿ SPINAL TRAY
• Type of Device: SPINAL TRAY
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 7974545
• MDR Text Key: 124333020
• Report Number: 1625685-2018-00045
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904057336
• UDI-Public: 00382904057336
• 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: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 405733
• Device Lot Number: 0001253521
• Date Manufacturer Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other