MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CARDIAC CATH PACK (BS79I)201; GENERAL SURGERY TRAY (KIT)

Model Number	SAN47BS797
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record for the blue or towels pwtb04-stm, lot#20180329-23-sh shows that the product was manufactured on 11th apr 2018.Based on the supplier¿s investigation, the device history record review did not indicate any exception that would have led to the reported incident.Evaluation of the device history record shows the average linting data was 0.21g/10 pieces, an acceptable range.No sample was provided for evaluation at this time.The or towel is made of cotton, so lint is born and inevitable.The intended use of or 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 is within the acceptable range.There is no abnormal situation that has happened in production.Therefore, the root cause could not be determined and no further action.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 or Problem Description
The customer reported that lint from the blue or towels pwtb04-stm from catalog san47bs797, cardiac catheter pack was noticed on the sterile field and sticking to a coronary catheter during a left heart angiogram procedure by the doctor.Doctor rinsed off the catheter with saline and continued on with the case.There was no injury.No patient demographics were provided.The actual date of the complaint is unknown.

• Brand Name: CARDIAC CATH PACK (BS79I)201
• Common Device Name: 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
• MDR Report Key: 8294895
• Report Number: 1423537-2019-00259
• Device Sequence Number: 19385791
• Product Code: LRO
• UDI-Device Identifier: 10888439184075
• UDI-Public: 10888439184075
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SAN47BS797
• Device Catalogue Number: SAN47BS797
• Device Lot Number: 982832
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other