MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE STEWARD ROCKLEDGE CATH RRS PK (CLWHE)180; GENERAL SURGERY TRAY (KIT)

Model Number SANHFCLWHE

Device Problem Degraded (1153)

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

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

Based on supplier investigation, the device history record could not be reviewed as the lot number was not provided.Supplier reviewed records in the last 2 years, no abnormal situation was found.No sample was returned for this investigation.From the investigation, there was no abnormal situation which occurred in production.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, but supplier will continue to monitor the trend of this type of incident.According to supplier, or towel is made of cotton, so cotton fiber is born.Supplier 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/(b)(4) pieces).In the folding process, supplier used one cloth pad under (b)(4) pieces semi-finished products to avoid linting stuck onto the products during product's transfer.

Event Description

Based on information received from the customer reportedly there is lint on towels pwtb04-stm.Allegedly it has gotten on devices, gloves, drapes, anything the towels touch.Per the customer, there was no injury and no patient affected.

• Brand Name: STEWARD ROCKLEDGE CATH RRS PK (CLWHE)180
• 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: 10747317
• MDR Text Key: 214807452
• Report Number: 1423537-2020-00556
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10888439643848
• UDI-Public: 10888439643848
• 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
• Type of Report: Initial
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SANHFCLWHE
• Device Catalogue Number: SANHFCLWHE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other