MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CPT, PACEMAKER PACK (PPSHC)606; CARDIOVASCULAR PROCEDURE KIT

Model Number	SCVHFPPSHD
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
From the device history record, lot# 20190724-23sh was manufactured on 01st aug 2019.Based on supplier investigation, device history record review did not indicate any exception that could lead to the reported incident.The average linting data is 0.198g / 10 pieces.No sample was returned for investigation.According to supplier, or towel is made of cotton, so cotton fiber is born.Supplier is 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/10 pieces).In the folding process, supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.From the investigation, there is no abnormal situation happened in production.Therefore, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, but supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
Customer reported linting of the blue or towels pwtb04-stm from the pacemaker pack scvhfppshd.Lint was found on equipment and gloves during the pacemaker case.Towels were removed from case and there was no injury to the patient.The customer provided no further information or data after multiple attempts.
Additional Manufacturer Narrative
Supplemental report is being filed since a sample from the customer was received following the filing of the initial mdr report submitted on 2/24/2020.One piece of the operation room towel # (b)(6) from the pacemaker pack catalog # scvhfppshd was returned for investigation.From the investigation there is no obvious lint falling from the surface of the towel.From the investigation, there is no abnormal situation happened in production.Therefore, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, but supplier will continue to monitor the trend of this type of incident.

• Brand Name: CPT, PACEMAKER PACK (PPSHC)606
• Common Device Name: CARDIOVASCULAR PROCEDURE 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: 9765203
• Report Number: 1423537-2020-00433
• Device Sequence Number: 16939671
• Product Code: OEZ
• UDI-Device Identifier: 10888439513899
• UDI-Public: 10888439513899
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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: SCVHFPPSHD
• Device Catalogue Number: SCVHFPPSHD
• Device Lot Number: 328121
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 03/26/2020
• 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