MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE HEART CATH DRAPE PACK (HCJMC)644; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	SAN43HCJMD
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, device history record (dhr) review did not indicate any exception that could lead to the reported incident.A review of the device history record for the lot number reported, 20191026-23-sh, revealed the towel was manufactured on november 1st, 2019.The average linting data is 0.155g/10 pieces.No sample available at the time of investigation.According to supplier, operating room towel is made of cotton, so cotton fiber is born.The 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/10pieces).In the folding process, supplier used one cloth pad under 100pieces semi-finished products to avoid linting stuck onto the products during product's transfer.Based on the investigation, there were no abnormalities found during production of the operating room towels; therefore, the root cause could not be determined.The complaint information was shared with the relevant sectors for their awareness.No action taken at this time, but the supplier will continue to monitor trends for this type of incident.
Event or Problem Description
Customer reported blue towels (pwtb04-stm) in kit (san43hcjmd) shedding a lot of lint during peripheral interventional procedure.When the towels stay wet in the bowl, blue lint was found at the bottom of the bowl and reportedly it causes the wires to get caught up in the blue towels.The towels were used to hold the wires down on the table and for excess flow of blood from the access site sheath.Lint found on wires and in the water bowls was manually removed.No injury or adverse effect reported.

• Brand Name: HEART CATH DRAPE PACK (HCJMC)644
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY 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: 11334789
• Report Number: 1423537-2021-00597
• Device Sequence Number: 19110539
• Product Code: OEQ
• UDI-Device Identifier: 10888439623567
• UDI-Public: 10888439623567
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2021

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: SAN43HCJMD
• Device Catalogue Number: SAN43HCJMD
• Device Lot Number: 454896
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 02/16/2021
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 118