MAUDE Adverse Event Report: MEDLINE INDUSTRIES VASCULAR PACK; STERILE DISPOSABLE TOWELS

Model Number DYNJ49366

Device Problem Material Integrity Problem (2978)

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

Event Date 04/10/2018

Event Type  malfunction  

Event Description

Medline vascular pack opened to set up for a case.Two different styles of towels identified in the pack; one loose weave, high linting, and one tight weave, non/low-linting.Staff members expressed concerns that the lint from the high linting towels is noticed on their instruments and equipment throughout the case and that it could potentially embolize in the patient during a vascular case.

• Brand Name: VASCULAR PACK
• Type of Device: STERILE DISPOSABLE TOWELS
• Manufacturer (Section D): MEDLINE INDUSTRIES
• MDR Report Key: 7494335
• MDR Text Key: 107705281
• Report Number: MW5077072
• Device Sequence Number: 1
• Product Code: KKX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: DYNJ49366
• Device Catalogue Number: DYNJ49366
• Was Device Available for Evaluation?: No
• 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
• Patient Outcome(s): Other