MAUDE Adverse Event Report: 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR; ANESTHESIA TRAY

Catalog Number 400866

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 04/28/2020

Event Type  Injury  

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 an 25gx3.5in whit 5ml glaspak bupi clear contained anesthesia that was ineffective.The following information was provided by the initial reporter: "it was reported the bupivacaine was ineffective in this lot.".

Event Description

It was reported that an 25gx3.5in whit 5ml glaspak bupi clear contained anesthesia that was ineffective.The following information was provided by the initial reporter: "it was reported the bupivacaine was ineffective in this lot.".

Manufacturer Narrative

H.6.Investigation: a review of the device history record noted no issues relating to the reported failure mode for 400866 lot # 0001343142.A sample was not returned for evaluation.Retained samples were reviewed and confirmed as visually acceptable.The investigation was not able to identify or confirm any manufacturing contribution to the reported failure mode.All indicators suggest the product contained a drug with acceptable potency.Previous corrective actions, capa#67717, have already been implemented for ineffective anesthesia.H3 other text : see h.10.

• Brand Name: 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR
• Type of Device: ANESTHESIA TRAY
• MDR Report Key: 10070806
• MDR Text Key: 193618296
• Report Number: 1625685-2020-00046
• 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,use
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 400866
• Device Lot Number: 0001343142
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention