FDA Adverse Event Malfunction Summary report: N

MEDLINE INDUSTRIES, INC.

MDR report key: 11693346 · Received April 20, 2021

Report

Report Number
11693346
Event Type
Malfunction
Date Received
April 20, 2021
Date of Event
March 18, 2021
Report Date
March 19, 2021
Manufacturer
MEDLINE INDUSTRIES, INC.
Product Code
GDY
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MI
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

ADULT MALE PRESENTED TO OPERATING ROOM FOR ANTERIOR LUMBAR INTERBODY FUSION WITH FLUOROSCOPY. DURING THE COURSE OF THIS PROCEDURE THE SURGEON PACKED A LAPAROTOMY SPONGE IN THE PATIENT'S ABDOMEN AND THEN REQUESTED A FLUOROSCOPY IMAGE. THE SURGEON COULD NOT LOCATE THE PACKED SPONGE ON THE IMAGE. HE ALERTED THE REST OF THE SURGICAL TEAM, AND THE CIRCULATING NURSE NOTIFIED MANAGEMENT, WHO CAME TO THE ROOM. THE SURGEON DEMONSTRATED WHAT HAD OCCURRED. THE PROCESS WAS THEN REPEATED WITH A NEW SPONGE FROM THE SAME LOT, ONE WAS VISIBLE WHEN DRY BUT NOT VISIBLE UPON BECOMING MOISTENED WITH BLOOD. ANOTHER SPONGE FROM THE SAME LOT WAS VISIBLE DRY AND WHEN MOISTENED. THE SPONGES INVOLVED WERE MEDLINE 8X36 IN. LAPAROTOMY SPONGES. THERE WAS NOTHING UNUSUAL ABOUT THE APPEARANCE OF THE SPONGES AND THE PACKAGING INDICATED THAT THE SPONGES WERE X-RAY DETECTABLE. ALL SPONGES FROM THIS LOT WERE SUBSEQUENTLY REMOVED FROM OR AND CSR STOCK. SURGERY PROCEEDED AS PLANNED. ALL COUNTS WERE CORRECT AT THE END OF THE PROCEDURE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
594045 MEDLINE INDUSTRIES, INC. GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY MEDLINE INDUSTRIES, INC. MDS251536LF 26020090001

Patients

Seq Age Sex Outcome Treatment
1 18980 DA