MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; TRAP, STERILE SPECIMEN

Model Number DYND44180

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2022

Event Type  malfunction  

Event Description

Situation: contaminated sterile product identified.Rn obtained sputum trap with sealed/intact packaging to collect ordered sample from her patient.Upon opening package, rn noted dead insect inside of the sample collection tube which should be sterile.Rn obtained second sputum trap, and upon opening again thought she saw a contamination in the collection tube.Rn appropriately sequestered products before reaching the patient.First product still contains insect (tape applied to open end after discovery to maintain sample), second product with no visible contamination remaining but requested for review of lot#s.Third package obtained by rn appeared intact/uncontaminated and used to collect sputum culture.Pictures to be emailed separately to pi team tagged with this rl#.Sequestered product located in psm office on np9.Manufacturer response for sputum trap, sputum trap (per site reporter) [redacted date] sample retrieved.[redacted date] emailed [redacted name].[redacted date] rma/fed-x label received.[redacted date] sample shipped.

• Brand Name: MEDLINE
• Type of Device: TRAP, STERILE SPECIMEN
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 16067573
• MDR Text Key: 306347294
• Report Number: 16067573
• Device Sequence Number: 1
• Product Code: BYZ
• 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: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYND44180
• Device Catalogue Number: DYND44180
• Device Lot Number: 55822010001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1