MAUDE Adverse Event Report: HOSPIRA, INC. BUPIVACAINE/MARCAINE; ANESTHESIA CONDUCTION KIT

Lot Number DY3797

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 09/15/2021

Event Type  malfunction  

Event Description

Operating room staff were attempting to draw up "marcaine" for use in an or case, when they looked into the syringe they had drawn up in medication and noticed something dark colored floating around.Staff investigated, and it appears the dark pieces floating around are pieces of the rubber seal that is punctured when medication is drawn up.It appears to have happened with numerous bottles.This poses a danger to the patient if the rubber pieces made it into the patient via the medication and syringe.I am unsure of the manufacturer of the bottle, just who the manufacturer of the medication is.There is minimal information on the medication bottles about udi# and other identifying numbers.

• Brand Name: BUPIVACAINE/MARCAINE
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): HOSPIRA, INC.; 375 n. field dr; lake forest IL 60045
• MDR Report Key: 12623161
• MDR Text Key: 276151317
• Report Number: 12623161
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: DY3797
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/01/2021
• Event Location: Other
• Date Report to Manufacturer: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1