MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE OPEN HEART PACK (OHCHX)882; ORTHOPEDIC TRAY

Model Number SCV33OHC14

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

From our device history record, lot#20210303-23-sh was finished on (b)(6) 2021.No exception was recorded in the device history record that could lead to the reported incident.Based on supplier investigation, device history record (dhr) review did not indicate any exception that could lead to the reported incident.The average linting data is 0.142g/10pcs.No sample was available 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: suction 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 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.From the investigation, no abnormal situation happened in production or dhr.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 Description

Customer reported increased linting with blue or towels pwtb04-stm from the open heart pack scv33ohc14 during a pediatric open heart procedure.Customer stated there was no adverse event.Report being filed for potential risk.

• Brand Name: OPEN HEART PACK (OHCHX)882
• Type of Device: ORTHOPEDIC TRAY
• 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: 12507685
• MDR Text Key: 272528328
• Report Number: 1423537-2021-00675
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10195594235277
• UDI-Public: 10195594235277
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCV33OHC14
• Device Catalogue Number: SCV33OHC14
• Device Lot Number: 658233
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2021
• Date Device Manufactured: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other