MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE LEFT HEART PK 29668 (OHRMG)640; GENERAL SURGERY TRAY (KIT)

Model Number	SCV15OHRMH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
Event or Problem Description
The customer reported that the white absorbent towel a8520bn from the left heart pack, scv15ohrmh deposited loose fibers into the saline flush bowl after being dipped in.No patient demographics were provided nor was any injury reported.The mdr is being filed for potential risk.
Additional Manufacturer Narrative
Mdr follow-up report being filed on the white absorbent towel a8520bn from the left heart pack, scv15ohrmh that had deposited loose fibers into the saline flush bowl after being dipped due to the investigation results are available.Based on supplier investigation, device history record could not able to be reviewed as lot number was not provided.No sample was available for investigation, only photos showing lint in the saline water.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.After linting test method performed results were (=0.38g/10 pieces).Based on the investigation, all linting test data is within the acceptable range.Based on the limited information available at this time and no product sample provided, the root cause could not be determined.If a sample is provided at a later date, the investigation will be re-opened, and an addendum report will be provided.

• Brand Name: LEFT HEART PK 29668 (OHRMG)640
• 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: 8640910
• Report Number: 1423537-2019-00319
• Device Sequence Number: 19588089
• Product Code: LRO
• UDI-Device Identifier: 10887488901657
• UDI-Public: 10887488901657
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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: SCV15OHRMH
• Device Catalogue Number: SCV15OHRMH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 06/20/2019
• 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