MAUDE Adverse Event Report: C. R. BARD, INC. DAVOL SUCTION CATHETER; CATHETER, IRRIGATION

Lot Number 579882

Device Problems Corroded (1131); Device Emits Odor (1425); Battery Problem (2885)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2021

Event Type  malfunction  

Event Description

During robotic case the crna, rn and techs in the room noticed a burning/chemical smell coming from up at the head of the bed near the anesthesia machine.The pod leader was notified, and she came in and inspected the equipment.She called the front desk and let the biomed/engineering department know.Someone from that department came up and looked at the equipment and could not find anything either.The pod leader had a stryker representative come in and look at the neptune and they changed the filter on that just in case.The smell came in waves throughout the case and biomed came up one more time to take a look.They suspected the anesthesia machine being the issue.The crna and anesthesiologist said they couldn't see anything on their end malfunctioning and the patient was safe.It was determined to finish the case and have the machine looked over in between cases.At the end of the case, we were cleaning up and took down the suction irrigator and one of the nurses said let look at that piece of equipment and we all smelled it and that was the source of the smell.We opened the part that contains the batteries and saw some fluid had entered that part and was corroding the batteries and the electrical smell was very strong.I asked the crna if she still wanted the machine looked at and she said no, and i followed up with biomed and let him know we did not need them to look at it as well.I took the pack sheet and the irrigator and have those placed in the drawer for equipment that has malfunctioned.

• Brand Name: DAVOL SUCTION CATHETER
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 12680863
• MDR Text Key: 277921374
• Report Number: 12680863
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 579882
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA