MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CATH PACK (CPBMJ)463; GENERAL SURGERY TRAY (KIT)

Model Number SAN22CPBM3

Device Problem Material Frayed (1262)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record for the blue non-xray towels (b)(4), lot # 11sa04-sh was manufactured january 2019.Based on the investigation, the device history record review did not indicate any exception that would have led to the reported incident.The supplier checked on the retained sample.(b)(4).No sample was provided for evaluation at this time.The operating room towel is made of cotton, so lint is born and inevitable.The intended use of operating room towel is to be used for applying medication to or absorbing small amounts of body fluids from a patient's body surface.Measures to better control and improve linting have been implemented.A suction process was added before products' final folding and operators perform this activity according to standard operation procedure requirements.In the folding process, one cloth bag protects 100 pieces of semi-finished products to avoid linting stuck onto the products during product transfer.Based on the investigation, all linting test data was within the acceptable range.There was no abnormal situation that had happened in production.Therefore, the root cause could not be determined and no further action taken.The complaint information was shared with the relevant sectors within the manufacturing facility for their awareness and we will continue to monitor for this type of incident.

Event Description

The customer reported linting of the blue non-xray towels (b)(4) from the catheterization kit san22cpbm3.No detailed complaint information, patient demographics operating room clinical data was provided after multiple attempts to retrieve from customer.There was no patient injury reported.An mdr is being filed based on potential risk.

• Brand Name: CATH PACK (CPBMJ)463
• 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: 8687069
• MDR Text Key: 148446254
• Report Number: 1423537-2019-00323
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10888439444476
• UDI-Public: 10888439444476
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SAN22CPBM3
• Device Catalogue Number: SAN22CPBM3
• Device Lot Number: 204970
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other