MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CATH LAB TRAY 836; GENERAL SURGERY TRAY (KIT)

Model Number SAN38CLRVA

Device Problem Degraded (1153)

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

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

From the device history record, lot number 20200527-23-sh was finished on 06/04/2020.No exception was recorded in the device history record that could lead to the reported incident.The sample was returned, however, only pictures could be provided to plant for investigation due to covid-19.The pictures showed a little nep, a nep can be defined as a small knot (or cluster) of entangled fiber found on the surface of the product.From the investigation, there is no abnormal situation which occurred during production and device history record.Therefore, the root cause could not be determined for this case.The complaint information was informed to the relevant personnel for their awareness.There is no action taken at this time, however, cardinal health will continue to monitor the trend of this type of incident.According to our supplier, operating room towel is made of cotton, so cotton fiber is born.Cardinal health works continuously with our supplier 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.((b)(4)).In the folding process, supplier used one cloth pad under 100pieces semi-finished products to avoid linting stuck onto the products during product's transfer.

Event Description

Based on information received from the customer, the operating room towels are reportedly linting.Allegedly, they have a significant amount of lint on them.No injury was reported, as the towels were thrown out and new sterile towels were utilized for the case.

• Brand Name: CATH LAB TRAY 836
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer (Section G): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 10801109
• MDR Text Key: 217298743
• Report Number: 1423537-2020-00558
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10887488641928
• UDI-Public: 10887488641928
• 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,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SAN38CLRVA
• Device Catalogue Number: SAN38CLRVA
• Device Lot Number: 475987
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 93