MAUDE Adverse Event Report: CARDINAL HEALTH SHANGHAI TOWEL OR 17X24IN GREEN STERILE 4/PK; GENERAL SURGERY TRAY (KIT)

Model Number 28200-004

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

Based on the supplier investigation, a review of the device history record did not indicate any exception that could lead to the reported incident.No sample was available for investigation.The average linting data is 0.170g / 10 pieces.According to the supplier, the or towel is made of cotton, so cotton fiber is born and inevitable.The supplier is continuously working with cardinal health to better control the linting and have implemented several measures to improve it: suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process.The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38g/10 pieces).In the folding process, supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.From the investigation, there is no abnormal situation happened in production.Therefore, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, but we will continue to monitor the trend of this type of incident.(b)(4).

Event Description

Disposable operating room towels used during endovascular case to drape the patient and back table were linting.Access was made with a micropuncture, which was flushed prior to use along with micropuncture sheath.When access was made into vessel and the micropuncture sheath which had been inserted into the patient's blood vessel was removed and replaced with a 5f sheath, the micropuncture sheath was flushed and inside the lumen on the micropuncture sheath was approximately 3/4 inch piece of green lint.Doctor was immediately notified.Careful observation was made to reduce potential for more linting on supplies.The patient did not require any additional medical care or medication.

• Brand Name: TOWEL OR 17X24IN GREEN STERILE 4/PK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): CARDINAL HEALTH SHANGHAI; f20, tower 1, kerry everbright; shanghai 20007 0; CH 200070
• Manufacturer (Section G): CARDINAL HEALTH SHANGHAI; f20, tower 1, kerry everbright; shanghai 20007 0; CH 200070
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874152
• MDR Report Key: 9857934
• MDR Text Key: 196389829
• Report Number: 1423537-2020-00438
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 28200-004
• Device Catalogue Number: 28200-004
• Device Lot Number: 190924-04-SH
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/19/2020
• Date Manufacturer Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1