MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. BIOHAZARD BAGS 6 X 9; CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE

Model Number REF DYND30261

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Small bugs found in multiple 6 x 9 biohazard bags from main operating room distribution.Ref dynd30261, reorder number (b)(4).Fda safety report id # (b)(4).

• Brand Name: BIOHAZARD BAGS 6 X 9
• Type of Device: CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 12568957
• MDR Text Key: 274928285
• Report Number: MW5104344
• Device Sequence Number: 1
• Product Code: NNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF DYND30261
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1