MAUDE Adverse Event Report: CARDINAL HEALTH KERLIX AMD ROLL 4.5INX4.1YDS; DRESSING,WOUND,OCCLUSIVE

Model Number 3332

Device Problem Material Disintegration (1177)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that they have recently been noticing more issues with loose threads from the kerlix as most people don¿t use the whole roll and must cut the roll shorter.Once cut, the ends are constantly flaking off threads that get stuck on their wounds base.Per customer, one of the surgeons asked to stop using it on his patient.The customer is concerned about a foreign body being loose on wound beds as they are small and sometimes not removed by junior staff during dressing changes.Additional information was received and stated that this gauze is being used on surgical abdominal wound and coccyx pressure injuries.Per customer, the kerlix gauze is being used in both surgical setting and non-surgical setting.There was no patient harm reported.

Manufacturer Narrative

An unused sample from the lot number 21g064462 was received.The device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The product was manufactured on 21-aug-2021.There was no evident of fraying in the roll.The site has proceeded to cut the roll with a scissor and the reported issue was observed.Several loose threads at the cut edge were observed.When cutting the roll, it breaks the selvage edge, leads to flaking off threads.A selvage¿s main purpose is to prevent unraveling or fraying, which makes the fabric stable and secure.As per customer comment, cutting the rolls to adjust to patient needs is their common practice.Therefore, the root cause is determined as a user error.The kerlix roll is not designed to be cut.At this time, a corrective and preventive action is not deemed necessary.The current process is running according to product specifications, meeting all quality acceptance criteria.This complaint will be used for qa tracking and trending purposes.

• Brand Name: KERLIX AMD ROLL 4.5INX4.1YDS
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 1430 marvin griffin road, po b; augusta GA 30906
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16292621
• MDR Text Key: 308826808
• Report Number: 1018120-2023-00476
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 20884521020037
• UDI-Public: 20884521020037
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 3332
• Device Catalogue Number: 3332
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1