MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE ANGIOGRAPHY PACK (ANWRB)612; GENERAL SURGERY TRAY (KIT)

Model Number	SAN22ANWRC
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/1979
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the supplier investigation, the device history record could not be reviewed as lot number was not provided.A sample was not available at the time of the investigation.According to supplier, or towel is made of cotton, so lint is born and inevitable.The supplier is continuously working with cardinal health to better control the linting and has 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
The customer reported linting of the blue or towels pwtb04-stm from the angiography pack san22anwrc during a cardiac catheter procedure.Lint was found on gloves, towels and in fluid containers.The towels were used over top of drape to absorb excess fluid.No apparent negative patient outcomes occurred during the procedure.The procedure was completed after gloves were changed, linting towels removed and fluid containers were emptied.Although there was no injury, cardinal health is filing a medwatch report for potential risk to patient.
Additional Manufacturer Narrative
Supplemental report is being filed since 4 pieces of the blue operating room towels pwtb04-stm were returned for investigation.There is no obvious lint falling from the surface of the towel.The linting test data is 0.09g / 4 pieces.According to supplier, or towel is made of cotton, so lint is born and inevitable.The supplier is continuously working with cardinal health to better control the linting and has implemented several measures to improve it: a.Suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process.B.The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.C.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38g/10 pieces).D.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.

• Brand Name: ANGIOGRAPHY PACK (ANWRB)612
• 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
• 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 ; 8478874141
• MDR Report Key: 9604635
• Report Number: 1423537-2020-00394
• Device Sequence Number: 16234866
• Product Code: LRO
• UDI-Device Identifier: 10887488564388
• UDI-Public: 10887488564388
• 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 Facility
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

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: SAN22ANWRC
• Device Catalogue Number: SAN22ANWRC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 02/17/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown