MAUDE Adverse Event Report: CAREFUSION, INC 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR; N/A

Catalog Number 400866

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

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 25gx3.5in whit 5ml glaspak bupi clear was used and the anesthesia was ineffective.This was discovered during use.The following information was provided by the initial reporter: material no.: 400866, batch no.: 1280749.It was reported that during a spinal procedure involving a spinal syringe the patient was feeling pain due to a possible issue with the effectiveness of the meds in the tray.

Event Description

It was reported that 25gx3.5in whit 5ml glaspak bupi clear was used and the anesthesia was ineffective.This was discovered during use.The following information was provided by the initial reporter: material no.: 400866 batch no.: 1280749 it was reported that during a spinal procedure involving a spinal syringe the patient was feeling pain due to a possible issue with the effectiveness of the meds in the tray.

Manufacturer Narrative

H.6.Investigation summary three physical samples were provided for evaluation by our quality engineer team.Each of the provided samples was visually inspected; however, no defects were observed.The liquid within each drug vial was found to be clear without any signs of visible particulate matter.A device history record review was performed for the provided lot number and the review did not reveal any detected abnormalities during the production process.A review of the temperature monitoring system within the manufacturing facility did not identify any excursions that would have negatively affected the raw material drug components used in this product.Based on the investigation results, a definitive cause for this incident could not be identified.Our vendor has been made aware of this incident and our quality team will continue to monitor the production process for this defect.

• Brand Name: 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR
• Type of Device: N/A
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 9251339
• MDR Text Key: 195566576
• Report Number: 1625685-2019-00122
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 400866
• Device Lot Number: 0001280749
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 74