MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KENDALL; TAPE AND BANDAGE, ADHESIVE

Model Number 3615C

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Reaction (2414); Low Oxygen Saturation (2477)

Event Date 02/06/2020

Event Type  malfunction  

Event Description

Patient was to have spine surgery.Patient had latex/natural rubber precautions r/t spinal bifida.Prior to bringing patient into operating room, products that contained latex for patient care were replaced with latex-free options.Immediately after applying 4-inch positioning tape to patient's leg for traction, patient's vital signs desaturated.Anesthesia was called immediately to operating room and patient was stabilized.Surgical procedure was then cancelled.Later in day the surgeon and staff learned that the 4-inch positioning tape ref # 3615c used is composed of latex and natural rubber.However, tape is removed from outer packaging and placed on exchange cart - label nor roll states latex- only outer box from purchasing states latex.This is an item that is used regularly in the operating room esp orthopedics as a positioning aid.

• Brand Name: KENDALL
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 9835163
• MDR Text Key: 183519227
• Report Number: 9835163
• Device Sequence Number: 1
• Product Code: KGX
• 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: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3615C
• Device Catalogue Number: 3615C
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4745 DA