MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ACCUSORB LAPAROTOMY SPONGES, USP TYPE VII; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Catalog Number NON21430LF

Device Problems Material Frayed (1262); Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2018

Event Type  malfunction  

Event Description

Medline x-ray detectable gauze type vii was used during the surgical procedure and we experienced a defective/poor quality gauze.Gauze frayed and pulled away in strands.Called or manager and reported issue.Doctor was made aware.

• Brand Name: ACCUSORB LAPAROTOMY SPONGES, USP TYPE VII
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7989531
• MDR Text Key: 124508846
• Report Number: 7989531
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NON21430LF
• Device Lot Number: 6051806005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21170 DA