MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE PEDIATRIC CARDIAC CATH PACK (PD00I)816; GENERAL SURGERY TRAY (KIT)

Catalog Number	SAN57PD00J
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the or towel (catalog# pwtb04-stm) in their pediatric cardiac cath pack (catalog# san57pd00j) was linting.Although the customer has stated this was "caught just in time" and there was no patient involvement, cardinal health is proactively filing this medwatch.The lot# was provided, therefore the device history record was reviewed, and no exception was indicated that could lead to the reported incident.As of this date, the sample has not been received by the manufacturing facility for evaluation.The or towel is made of cotton, so lint is inborn and inevitable.The measures used to control and improve linting include: a.Suctions machines are installed in the cloth rolling process, dyeing process and cutting process b.The suction process was added before the product's final folding, and workers do it according to standard operation procedure requirements.C.Linting test method and acceptable criteria are stipulated to see the suction results (=0.38g/10 pieces).D.In the folding process, one cloth pad is under/protects 100 pieces semi-finished product to avoid lint sticking during product transfer.Based on the investigation, there is no abnormal situation that happened during production, therefore the root cause could not be determined and no action will be taken at this time the complaint information was shared with the relevant sectors for their awareness, and we will continue to monitor complaints for this type of incident.If the sample is received, then it will be evaluated and a follow up report will be filed.
Event or Problem Description
The customer reported that the or towel in their pediatric cardiac cath pack was linting.Per customer, this was "caught just in time" and there was no patient involvement.No other information about the patient, the procedure, or the event date were provided.
Additional Manufacturer Narrative
Supplemental report is being filed since two pieces of the or towel # pwtb04-stm from the pediatric cardiac cath pack catalog# san57pd00j were returned for investigation.The device history record review did not indicate any exception that could lead to the reported incident.The average linting data is 0.137g / 10 pieces.From the sample evaluation, there was no abnormality found.A suction test was conducted and the linting test data is 0.02g / 2 pieces.From the investigation, no abnormal situation happened in production and all linting test data were within the acceptable range.The root cause could not be determined, and no further action will be taken at this time.The complaint information was provided to the relevant manufacturing sectors for their awareness and we will continue to monitor the trend of this type of incident.

• Brand Name: PEDIATRIC CARDIAC CATH PACK (PD00I)816
• 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: 8993008
• Report Number: 1423537-2019-00343
• Device Sequence Number: 11276984
• Product Code: LRO
• UDI-Device Identifier: 10888439212266
• UDI-Public: 10888439212266
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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 Catalogue Number: SAN57PD00J
• Device Lot Number: 249963
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 10/18/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other